NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Appraisal Consultation Document
Ultrasound locating devices for placing central venous lines
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The Department of Health and the National Assembly for Wales have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of ultrasound locating devices for placing central venous lines and provide guidance on its use in the NHS in England and Wales.The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of ultrasound locating devices for placing central venous lines. This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website). Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).
The key dates for this appraisal are: Closing date for comments: Tuesday 30 April 2002
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| Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. |
| 1 | Appraisal Committee's preliminary recommendations |
| 1.1 | It is recommended that 2-dimensional (2-D) imaging ultrasound guidance should routinely be used when a central venous line is being inserted in an elective or emergency situation. |
| 1.2 | All NHS Trusts where central lines are used should develop an implementation strategy that includes: |
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| The plan should ensure full implementation of this guidance by the end of the 2004/2005 financial year. | |
| 1.3 | Ultrasound guided central venous catheter insertion should be performed only by appropriately trained practitioners who are competent in using the technique. Healthcare practitioners will need to continue to use the landmark method until the required equipment and expertise becomes available for the use of 2-D imaging ultrasound. Trainers should not dispense with teaching the landmark method while implementation of routine use of ultrasound-guided elective insertion is underway. After implementation of this guidance, the theory of the landmark method should continue to be taught in case it should be required in an emergency situation when ultrasound equipment is not readily available. |
| 2 | Clinical need and practice |
| 2.1 | Central venous catheters (CVCs) are inserted for a number of reasons including haemodynamic monitoring, intravenous delivery of blood products and drugs (e.g. chemotherapy and antibiotics), haemodialysis, total parenteral nutrition, cardiac pacemaker placement and management of perioperative fluids. Central venous access (CVA) may be required for patients undergoing cancer treatment, dialysis, or coronary or other major surgery, and for those admitted to intensive therapy units (ITUs), high dependency units (HDUs) or accident and emergency departments. It has been estimated that about 200,000 CVA procedures are performed annually in the NHS. |
| 2.2 | CVA has traditionally been achieved by using puncture of a central vein (venepuncture), passing the needle along the anticipated line of the relevant vein by using surface anatomical landmarks and by knowing the expected anatomical relationship of the vein to its palpable, companion artery. This is known as the 'landmark method'. Surgical 'cut-down' is a less frequently used method for gaining CVA, and is more invasive. |
| 2.3 | Whilst experienced operators can achieve relatively high success rates using the landmark method with few complications, in the literature failure rates have been reported to be as high as 35%. |
| 2.4 | CVCs are inserted in a wide range of clinical settings by a diverse group of doctors including radiologists, anaesthetists, nephrologists, oncologists, surgeons, and general medical doctors. In the USA and increasingly in the UK nurse specialists are also undertaking CVCs. The range of settings in which CVCs are inserted includes operating theatres, emergency rooms, nephrology, oncology and other wards, radiology departments, ITUs and HDUs. |
| 2.5 | CVA can be achieved using various puncture sites but the most common are the internal jugular vein (IJV), the subclavian vein (SV), the femoral vein (FV), and upper limb veins (using peripherally inserted central catheters - PICCs). The choice of access route depends on multiple factors including the reason for CVA, the anticipated duration of access, the intact venous sites available and the skills of the operator. |
| 2.6 | The most common complications associated with CVA are arterial puncture, arteriovenous fistula, pneumothorax, nerve injury and multiple unsuccessful attempts at CVC, which delay treatment. The risks and the consequences of complications vary substantially across different patient groups depending on the patient's anatomy (for example, morbid obesity, cachexia, short neck, or local scarring from surgery or radiation treatment), the circumstances in which CVA is carried out (for example, for a patient receiving mechanical ventilation or during emergencies such as cardiac arrest) and co-morbidities (for example, bullous emphysema or coagulopathy). The National Confidential Enquiry into Perioperative Deaths recently reported that in a survey of over 3000 CVA procedures undertaken in the NHS, one fatality occurred as a result of a procedure-induced pneumothorax. |
| 3 | The technology |
| 3.1 | Ultrasound technology has long been used in interventional radiology to guide percutaneous procedures at sites such as the kidneys, liver, arterial and venous circulation, pleural cavity, gallbladder, joints and bowel. Real-time ultrasound guidance of CVC insertion provides the operator with visualisation of the desired vein and the surrounding anatomical structures before and during the insertion. The advantages of ultrasound-guided CVC placement include the identification of the precise position of the target vein and the detection of anatomical variants and of thrombosis within the vessel, together with the avoidance of inadvertent arterial puncture. Ultrasound guidance therefore has the potential to reduce the incidence of complications related to initial venous puncture which is the first stage of CVC placement, but would not affect the complications arising from the procedure as a whole. |
| 3.2 | Two types of real-time ultrasound guidance are described: 2-dimensional (2-D) imaging ultrasound guidance and audio-guided Doppler ultrasound guidance. 2-D imaging ultrasound, which is the more commonly used method, provides a real-time grey-scale imaging of the anatomy. Audio-guided Doppler ultrasound generates an audible sound from flowing venous blood, which helps the operator localise the vein and differentiate it from its companion artery. The portable ultrasound machines can be used in operating theatres, accident and emergency departments, ITUs, HDUs and radiology suites, as well as at the bedside on the hospital ward. |
| 3.3 | Operators need to be trained to use ultrasound-guided techniques. Training involves not only acquiring the necessary manual skills, but also having a basic understanding of ultrasound principles and being able to interpret ultrasound images. |
| 4 | Evidence and interpretation |
| The Appraisal Committee considered evidence from a number of sources (see Appendix B). | |
| 4.1 | Clinical effectiveness |
| 4.1.1 | Twenty randomised clinical trials (RCTs) were identified. Of these, six evaluated audio-guided Doppler ultrasound against the landmark method, thirteen evaluated 2-D ultrasound guidance against the landmark method and one evaluated both audio-guided Doppler ultrasound and 2-D ultrasound guidance against a control as well as each other. There were no trials that compared the use of ultrasound locating devices (ULDs) against the surgical cut-down method. |
| 4.1.2 | Insertion sites were the IJV (15 trials), SV (4 trials) or FV (1 trial). One trial did not specify the insertion point, and one investigated both the IJV and SV as insertion sites. None addressed the placement of PICCs or ports, both of which can be considered types of CVC. |
| 4.1.3 | For most of the trials, the setting within the hospital where the cannulation took place was not reported clearly. In six of the trials the CVC insertions took place in an ITU or trauma unit, and in two trials they took place in emergency rooms. In the seven studies involving patients scheduled for cardiac surgery, the cannulation is most likely to have taken place on the way into theatre. In only three of the trials does it seem likely that CVC insertion took place on wards or in clinics. |
| 4.1.4 | The CVA procedure was carried out by anaesthetists in seven studies and by medical staff in four studies. One study involved 2-D ultrasound-guided catheterisation by junior radiologists. None of the studies involved nurses. The remaining nine studies did not make the specialty or profession of the operator clear. The range of experience of the operator, both with respect to medical career and use of the intervention, differed greatly from study to study. Six studies described the operators as having up to 5 years' postgraduate experience, eight described them as having more than 5 years' experience, and two described them as varying in experience. Four trials did not record the career experience of the operator. |
| 2-D ultrasound imaging | |
| IJV | |
| 4.1.5 | Pooled results from seven RCTs suggested that real-time 2-D ultrasound guidance was significantly better than the landmark method for all five outcome variables measured for insertions into the IJV in adults. Compared with the landmark method, 2-D ultrasound guidance was associated with reduced risks of failed catheter placements (86% reduction in the risk, 95% confidence interval [CI] 67% to 94%, p < 0.001), catheter placement complications (57% reduction in risk, 95% CI 13% to 78%, p = 0.02), and failure on the first catheter placement attempt (41% reduction in risk, 95% CI 12% to 61%, p = 0.009), and fewer attempts to achieve successful catheterisation (on average, 1.5 fewer attempts, 95% CI 0.47 to 2.53, p = 0.004). The difference between the 2-D ultrasound method and the landmark method in time to successful catheterisation was small and not statistically significant (the 2-D ultrasound-guided catheterisation was 20 seconds faster, 95% CI ?83 to 124 seconds, p = 0.7). However, there was significant heterogeneity for this endpoint (p < 0.01), which indicated that it might not be appropriate to pool these results. When the analysis was repeated, excluding the outlier trial, heterogeneity was no longer significant and the pooled result from the included trials showed that catheterisation was, on average, 69 seconds faster (95% CI 46 to 92 seconds) with the ULD than with the landmark method, which was a highly statistically significant difference (p < 0.001). |
| 4.1.6 | Three trials evaluated the effect of 2-D ultrasound guidance on the cannulation of the IJV in infants. In these trials, 2-D ultrasound guidance was significantly better than the landmark method in terms of reductions in the risk of failed catheter placements (85% reduction in risk, 95% CI 36% to 97%, p = 0.01), the risk of catheter placement complications (73% reduction in risk, 95% CI 8% to 92%, p = 0.03), and the number of attempts to successful catheterisation (reduced by an average of 2, 95% CI 1.2 to 2.8, p = 0.001). Using the 2-D ultrasound guidance, the successful cannulation was achieved, on average, 349 seconds (95% CI ?103 to 802 seconds) more quickly than with the landmark method, although this result was not statistically significant (p = 0.13). |
| SV | |
| 4.1.7 | Only one RCT was identified that analysed the effect of 2-D ultrasound guidance on SV catheterisation in adults. In the trial, in comparison with the landmark method, 2-D ultrasound guidance was associated with reduced risks of catheter placement failures (86% reduction in risk, 95% CI 43% to 96%, p = 0.006) and catheter placement complications (90% reduction in risk, 95% 29% to 99%, p = 0.02). However, in this trial, the operators were relatively inexperienced in both the landmark method and the 2-D ultrasound guidance method. The failure rate with the landmark method was 55%, which is higher than that reported in trials that involved more experienced operators (around 9-19%). |
| 4.1.8 | No studies were found that investigated the effect of 2-D ultrasound guidance on SV catheterisation in infants. |
| FV | |
| 4.1.9 | One study was identified, which evaluated the effect of 2-D ultrasound guidance on femoral catheterisation in adults. No studies in infants were found. In this trial, the operators took, on average, 2.7 (95% CI 0.1 to 5.3) fewer attempts to insert a CVC using 2-D ultrasound guidance than using the landmark method (p = 0.04). Compared with the landmark method, 2-D ultrasound guidance reduced the risk of failed catheter placement and the time to successful catheterisation, but the differences were not statistically significant. |
| 4.1.10 | No studies were found that investigated the effect of 2-D ultrasound guidance on FV catheterisation in infants. |
| Audio-guided Doppler ultrasound | |
| IJV | |
| 4.1.11 | Four RCTs were found that compared audio-guided Doppler ultrasound guidance with the landmark method for IJV catheterisation in adults. Pooled results from these RCTs suggest that audio-guided Doppler ultrasound guidance was significantly better than the landmark method in terms risk of failed catheter placements (61% reduction in risk, 95% CI 8% to 83%, p = 0.03), and the risk of failure on the first catheter placement attempt (43% reduction in risk, 95% CI 12% to 63%, p = 0.01). With the audio-guided Doppler ultrasound method, the risk of catheter placement complications was reduced (57% reduction in risk, 95% CI -5% to 83%) and there were fewer attempts to successful catheterisation (0.6 fewer attempts, 95% CI ?0.6 to 1.8), although the differences did not reach statistical significance (p = 0.06 and p = 0.40, respectively), so they could arisen by chance. It took, on average, 35 seconds longer (95% CI -54 to 124 seconds) to successfully insert a CVC using Doppler ultrasound guidance than it did with the landmark method, although this difference was also not statistically significant (p = 0.4). |
| 4.1.12 | Only one trial was identified that studied the effect of audio-guided Doppler ultrasound in infants. The sample size of this study was small (n = 29) and so lacked statistical power. It failed to show any differences with the landmark method. |
| SV | |
| 4.1.13 | The pooled results from three RCTs (all involving adults) suggest that for SV catheterisation there was a significantly increased risk of failed catheter placement when the audio-guided Doppler ultrasound method was used than when the landmark method was used (48% increased in risk, 95% CI 3% to 114%, p = 0.03) - in other words the landmark method was preferable to the audio-guided Doppler ultrasound guidance technique. In contrast, the pooled results from two of the trials showed a 43% fall (95% CI 89% to 188%) in the risk of catheter placement complications in the audio-guided Doppler ultrasound group, although this result was not statistically significant (p = 0.5). |
| 4.1.14 | Only one study reported the effect of audio-guided Doppler ultrasound guidance on the risk of failure on the first catheter placement in adults. There was a slight increase (4%, 95% CI ?24% to 43%) in the risk of catheter placement complications associated with the use of audio-guided Doppler ultrasound guidance compared with the landmark method, although this result was not statistically significant (p = 0.8). Only one study recorded the effect of audio-guided Doppler ultrasound guidance on the number of attempts to successful catheterisation. This study found an average of 0.4 (95% CI 0.2 to 0.6) fewer attempts to successful catheterisation with the audio-guided Doppler ultrasound guidance method than with the landmark method, a highly statistically significant difference (p < 0.001). The same study was the only one to record the effect of Doppler ultrasound guidance on the time to successful catheterisation. Catheterisation by Doppler ultrasound guidance method was significantly (on average, 209 seconds, 95% CI 175 to 242) slower than by the landmark method (p < 0.001). |
| 4.2 | Cost effectiveness |
| 4.2.1 | No relevant economic evaluations were identified in the literature. Furthermore, none of the submissions made to the Institute included economic evaluations. |
| 4.2.2 | The Assessment Group developed an economic analysis, based on the evidence from the systematic review of RCTs, to evaluate the cost-effectiveness of 2-D ultrasound guidance compared with the landmark method. This model is a simple decision analytic model, and is based on a theoretical cohort of 1000 adult patients who required IJV cannulation before surgery and who had a low to moderate risk of complications. |
| 4.2.3 | This model adopted a set of conservative assumptions. It was assumed that: the operators were experienced in using the landmark method; the time to achieve successful punctures was the same for both methods; complications were limited to arterial puncture; there was a 10-minute delay between the prior failure and the new attempt at another insertion site; there was a 100% success rate at the second insertion site; and that each machine was used for 15 procedures per week. |
| 4.2.4 | The results of the Assessment Group's model suggested that the ultrasound guidance not only avoided 90 arterial punctures for every 1000 patients treated, but also reduced costs by an average of almost £2 per patient. In other words the 2-D ultrasound guidance method was found to be both more effective and less costly than the landmark method. |
| 4.2.5 | A threshold sensitivity analysis was undertaken to examine by how much key variables in the model needed to change to make the ultrasound guidance method cost-neutral instead of cost saving. The modelled result was most sensitive to the utilisation of the ultrasound equipment. The cost-saving result was eradicated if the number of assumed ultrasound procedures per machine per week was less than 10.6, or if the number of assumed ultrasound procedures per week per trained operator was less than 0.65. |
| 4.2.6 | Given that the model used relatively conservative estimates, the Assessment Group concluded that the results were probably generalisible to all anatomical catheter insertion sites, to infants, and to other sites within the hospital including the clinical wards. |
| 4.3 | Other key issues |
| 4.3.1 | Some concerns have been expressed that the wider availability of ultrasound machines for CVA may result in dependence on ultrasound imaging. In other words there is a potential for deskilling of operators in insertion of CVCs using the landmark method. In emergency situations where a line needs to be inserted without delay, and when the ultrasound unit is not readily available, insertions by the landmark method may still be appropriate. It is important to emphasise that training in ultrasound-guided insertion must not allow trainers to dispense with teaching the theory of the landmark methods. |
| 4.4 | Consideration of the evidence |
| 4.4.1 | The Committee reviewed the evidence on both the clinical effectiveness and the cost effectiveness of ultrasound locating devices for placing central venous lines, having also considered the evidence from clinical experts. Furthermore, the Committee was mindful of the need to ensure that its advice took account of the efficient use of NHS resources. |
| 4.4.2 | The Committee concluded that there was convincing evidence of both the clinical and cost effectiveness of 2-D imaging ultrasound guidance for placing CVCs. In addition, there would be important potential benefits for patients arising from reduced discomfort from the procedure and reduced risk of complications compared with the landmark method. |
| 4.4.3 | The Committee found the evidence for the use of audio-guided Doppler ultrasound guidance less satisfactory, and therefore concluded that the 2-D imaging ultrasound guidance should be used in preference to audio-guided Doppler ultrasound guidance. |
| 4.4.4 | While accepting that the 2-D ultrasound imaging guidance in placing CVCs is superior to the traditionally used landmark method, the Committee decided that the NHS Trusts should be allowed sufficient time to plan and implement this guidance given the financial and service implications of purchasing the required equipment and of training sufficient numbers of competent practitioners. The Committee felt that 2 years would be a realistic time frame for full implementation of this guidance. |
| 4.4.5 | The Committee also considered that although 2-D ultrasound imaging guidance in placing CVCs should eventually become the routine method for all procedures, the landmark method remained important in emergency situations when ultrasound equipment and/or expertise might not be immediately available. Consequently, the theory of the landmark method should continue to be taught. |
| 5 | Proposed recommendations for further research |
| 5.1 | Good quality studies are needed to investigate the possible economic and clinical implications to the NHS of the use of nurse specialist or other healthcare practitioners carrying out routine insertion of central venous lines. |
| 6 | Preliminary views on the resource impact for the NHS |
| This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible. | |
| 6.1 | The purchase cost of a portable ultrasound machine currently ranges between £7000 and £15,000. The additional disposables necessary for the ultrasound-guided procedure cost less than £1 per procedure. Estimates made by the Assessment Group analysis indicate that the additional cost of using ultrasound equipment for the CVA procedure is likely to be less than £10 per procedure. |
| 6.2 | The Assessment Group estimates that an additional 1342 machines might need to be purchased across the NHS in England and Wales, at a cost of around £15 million. Additional training costs will amount to £14 million, assuming that the training will be provided by a consultant radiologist, anaesthetist or surgeon. In subsequent years the training costs might be expected to fall as skills are cascaded downwards and the trained become trainers. This cost estimate does not include the trainee's time, or any capital cost requirement for training laboratories and dummies. Adding the training costs to the capital costs, the initial cost to the NHS is estimated to be around £29 million in the first 2 years. |
| 6.3 | The Assessment Group analysis suggests that in the long-term the implementation of ultrasonic locating devices will be cost-saving. However the majority of these savings are likely to be in staff, operating theatre and ITU/HDU time and bed resources rather than financial savings. |
| 6.4 | A constraint upon the implementation of this technology will be the need to ensure adequately trained competent operators to support the services. Many CVC insertion procedures are performed on an emergency basis at the bedside in a diverse number of locations and therefore the necessary skills need to be spread across several related disciplines. |
| 7 | Proposals for implementation and audit |
| This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1. All healthcare practitioners who insert central venous lines in either elective or emergency situations should review their current practice in line with the guidance set out in Section 1. | |
| 7.1 | To enable healthcare practitioners to audit their own compliance with this guidance, it is recommended that a system is available to identify patients who have a central line inserted in either an elective or an emergency situation. |
| 7.2 | To measure compliance locally with the guidance set out in Section 1, the following criteria should be used. Further details on suggestions for audit are presented in Appendix C. |
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| 7.3 | All NHS Trusts should identify the number of 2-D imaging ultrasound units required and the appropriate location for each unit and should plan to train a sufficient number of healthcare practitioners in a range of disciplines in the proper use of the units. |
| 8 | Related guidance |
| 8.1 | There is no related guidance for this technology. |
| 9 | Proposed date for review of guidance |
| The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review. | |
| 9.1 | It is proposed that the guidance on this technology is reviewed in July 2005. |
| Professor David Barnett |
| Chairman, Appraisal Committee |
| March 2002 |
| Appendix A. Appraisal Committee members |
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NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members appears below. The Appraisal Committee meets twice a month other than in December, when there are no meetings. The Committee membership is split into two branches, with the chairman, vice-chairman and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and topics are not moved between the branches. |
| Committee members are asked to declare any interests in the technology to be appraised. If there is a conflict of interest, the member is excluded from participating further in that appraisal. |
| The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declaration of interests, are posted on the NICE website. |
| Dr Jane Adam |
| Radiologist, St. George's Hospital, London |
| Professor R L Akehurst |
| Dean, School of Health Related Research, Sheffield University |
| Dr Sunil Angris |
| General Practitioner, Waterhouses Medical Practice |
| Professor David Barnett (Chairman) |
| Professor of Clinical Pharmacology, University of Leicester |
| Professor Sir Colin Berry |
| Professor of Morbid Anatomy, St Bartholomew's and Royal London School of Medicine |
| Dr Sheila Bird |
| MRC Biostatistics Unit, Cambridge |
| Professor Carol Black |
| Consultant Physician, Royal Free Hospital & UCL, London |
| Professor John Brazier |
| Health Economist, University of Sheffield |
| Professor Martin Buxton |
| Director of Health Economics Research Group, Brunel University |
| Professor Bruce Campbell (resigned February 2002) |
| Consultant Surgeon, Royal Devon & Exeter Hospital |
| Professor Mike Campbell |
| Statistician, Institute of General Practice & Primary Care, Sheffield |
| Dr Karl Claxton |
| Health Economist, University of York |
| Professor Sarah Cowley |
| Professor of Community Practice Development, Kings College, London |
| Dr Nicky Cullum |
| Reader in Health Studies, University of York |
| Professor Jack Dowie |
| Health Economist, London School of Hygiene & Tropical Medicine, London |
| Mr Chris Evennett |
| Chief Executive, Mid-Hampshire Primary Care Group |
| Dr Paul Ewings |
| Statistician, Taunton & Somerset NHS Trust |
| Professor Terry Feest |
| Clinical Director and Consultant Nephrologist, Richard Bright Renal Unit, and Chairman of the UK Renal Registry |
| Ms Jean Gaffin (resigned March 2002) |
| Formerly Executive Director, National Council for Hospice and Specialist Palliative Care Service |
| Mrs Sue Gallagher |
| Chief Executive, Merton, Sutton and Wandsworth Health Authority |
| Dr Trevor Gibbs |
| Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline |
| Sally Gooch |
| Director of Nursing, Mid-Essex Hospital Services Trust |
| Mr John Goulston |
| Director of Finance, The Royal Free Hampstead NHS Trust |
| Professor Trisha Greenhalgh |
| Professor of Primary Health Care, University College London |
| Liz Heyer (resigned March 2002) |
| Chief Executive, Barnet & Chase Farm Hospitals NHS Trust |
| Professor Philip Home |
| Professor of Diabetes Medicine, University of Newcastle |
| Dr Terry John |
| General Practitioner, The Firs, London |
| Dr Diane Ketley |
| Research into Practice Programme Leader, NHS Modernisation Agency |
| Dr Mayur Lakhani |
| General Practitioner, Highgate Surgery, Leicester, and Lecturer, University of Leicester |
| Ruth Lesirge |
| Patient Representative; Director, Mental Health Foundation |
| Dr George Levvy |
| Patient Representative; Chief Executive, Motor Neurone Disease Association |
| Dr Gill Morgan |
| CEO, North & East Devon Health Authority |
| Professor Miranda Mugford |
| Health Economist, University of East Anglia |
| Mr M Mughal |
| Consultant Surgeon, Chorley and South Ribble NHS Trust |
| Mr James Partridge |
| Chief Executive, Changing Faces |
| Siân Richards |
| General Manager, Cardiff Local Health Group |
| Professor Philip Routledge |
| Professor of Clinical Pharmacology, University of Wales |
| Dr Rhiannon Rowsell |
| Pharmaceutical Physician, AstraZeneca UK Ltd |
| Dr Stephen Saltissi |
| Consultant Cardiologist, Royal Liverpool University Hospital |
| Professor Andrew Stevens (Vice-Chairman) |
| Professor of Public Health, University of Birmingham |
| Professor Ray Tallis |
| Consultant Physician, Hope Hospital, Salford |
| Dr Cathryn Thomas |
| General Practitioner, and Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham |
| Professor Mary Watkins |
| Head of Institute of Health Studies, University of Plymouth |
| Dr Norman Waugh |
| Public Health Consultant, University of Southampton |
| Appendix B. Sources of evidence considered by the Committee | |
| The following documentation and opinion was made available to the Committee: | |
| A. |
Assessment Report prepared by the School of Health Related Research (ScHARR), University of Sheffield: The effectiveness and cost-effectiveness of ultrasound locating devices for central venous access, 24 January 2002
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| B. |
Manufacturer/sponsor submissions from:
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| C. |
Professional/specialist group submissionsfrom:
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| D. |
Patient/carer group submissions from:
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| E. |
Expert perspectives from:
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| Appendix C. Detail on criteria for audit of the use of ultrasound locating devices for placing central venous lines | |||
| Possible objectives for an audit | |||
| An audit on the appropriate use of ultrasound locating devices could be carried out to ensure that when central venous lines are being inserted in both elective and emergency situations 2-dimensional (2-D) imaging ultrasound guidance is used. | |||
| Possible patients to be included in the audit and time period for selection | |||
| All patients who have a central venous line inserted for any purpose on either an elective or emergency basis over a sensible period of time for audit data collection, for example, for 1 to 3 months. A sample of patients could be used for the audit stratified by clinical areas most likely to be involved, for example critical care areas, theatres, and accident and emergency, or the audit could be staged to include one clinical area at a time, working through all clinical areas. | |||
| Measures to be used as a basis for an audit | |||
| The measures to be used in an audit of patients who have a central venous line inserted for any purpose are as follows. |
| Criterion | Standard | Exception | Definition of Terms |
| 1. 2-dimensional imaging ultrasound guidance is used when a central venous line is being inserted | 100% of patients with a central venous line inserted | None | Include central venous lines inserted in any site (e.g. jugular, subclavian, femoral) |
| 2. The healthcare practitioner using the 2-D imaging ultrasound unit is trained in its use | 100% of patients in the audit | None | NHS Trusts will have to agree on the form and documentation of training records to be used for audit purpose |