Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
There are 3 studies summarised in this briefing. The evidence for Kendall DL includes 2 randomised controlled trials and 1 retrospective observational study, with a total of 36,146 surgery cases including cardiovascular surgery, general surgery and neurological surgery.
Table 2 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
The studies compared the rates of surgical site infections and false alarms between disposable (Kendall DL) and reusable electrocardiogram (ECG) cable and lead systems. Of the 3 included studies, 2 were randomised controlled trials, both of which recruited patients from a single medical centre in the US. The randomisation was by care units not patients (cluster study design). One trial was not blinded because of the colour of the ECG cables.
Both randomised controlled trials were funded by the company.
Table 2 Summary of selected studies
|
Study size, design and location |
A cluster randomised controlled trial of 7,939 patients who had cardiovascular surgery, general surgery or neurological surgery, and 7,240 were included in study analysis. |
|
Intervention and comparator(s) |
Disposable ECG LWs. Cleaned reusable ECG LWs. |
|
Key outcomes |
In a 12-month study period, there was no difference in total infection rate between disposable and reusable ECG LW based on 100 patient days. Also, there was no difference in rates of BSI, VAP and SSI between the intervention and control group. |
|
Strengths and limitations |
A large number of people were included but these patients were recruited from a single medical centre. This trial was not blinded. Randomisation was by intensive care units not patients (a cluster study design). The study was funded by the company. |
|
Study size, design and location |
A cluster randomised controlled trial of 1,611 patients having cardiac surgery in the US. |
|
Intervention and comparator(s) |
The Kendall DL disposable cable and LW system. Reusable ECG LWs. |
|
Key outcomes |
A total of 1,611 patients had 233 admissions (each of which counted as 1 case). The analysis based on all alarms recorded, showed that disposable ECG LWs led to a 29% reduction in no-telemetry, leads-fail and leads-off alarms (RR=0.71, 95% CI 0.53 to 0.96) during the 4-month period and showed statistical non-inferiority in monitoring alarms and false alarms (p=0.002). |
|
Strengths and limitations |
Randomisation was described in the study. A large number of patients were included but these patients were recruited from a single medical centre. Data were obtained by remote monitoring personnel who recorded alarm event occurrence and types of events, and this may affect the accuracy and completeness of data due to errors. Randomisation was by medical units not patients (a cluster study design). Study data collection and analysis were funded by the company. |
|
Study size, design and location |
A retrospective case-control study of 316 facilities where a total of 27,296 CABG procedures were done. |
|
Intervention and comparator(s) |
Kendall DL disposable cable and LW system. Reusable ECG lead wire. |
|
Key outcomes |
During the 12-month study period, 42 hospitals did 4,450 (16.3%) CABG procedures using single-use ECG cable and lead systems and 274 hospitals did 22,846 (83.7%) CABG procedures using reusable ECG leads. The incidence rates of SSIs were significantly lower in the single-patient-use ECG cable and lead wire group compared with reusable ECG lead wire group (3.3% compared with 4.4%, p=0.0403). There was a significant 25% reduction with the single-patient-use ECG cable and lead wire at 90 days after CABG (p=0.04) but a non-significant 14% and 21% reduction at 30 days (p=0.48) and 60 days (p=0.14) after CABG respectively. The incidence rates between 2 groups were not significantly different at 30 days (1.3% in single use ECG group compared with 1.6% in reusable ECG group, p=0.488) and 60 days (2.7% compared with 3.4%, p=0.1383). |
|
Strengths and limitations |
This is a retrospective study. The analysis was not patient level, but on the basis of the number CABG procedures performed at hospital level. |
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Abbreviations: BSI, bloodstream infection; CABG, coronary artery bypass grafting; CI, confidence internal; ECG, electrocardiogram; LW, lead wire; RR, relative risk; SSI, surgical site infection; VAP, ventilator associated pneumonia. |
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