Interventional procedure consultation document

Translaryngeal tracheostomy

Inserting a breathing tube from the windpipe to the outside of the neck

Some patients need the help of a machine (ventilator) to assist with breathing. This is normally done using a tube that passes into the windpipe (trachea) through the mouth. If a patient needs to be on a ventilator for more than a few days it is safer and more comfortable to have a breathing tube inserted directly into their windpipe through a hole in the front of the neck (a tracheostomy) rather than through the mouth. The translaryngeal tracheostomy procedure involves passing the breathing tube from inside the windpipe to the outside of the neck, as opposed to the usual technique in which the tube is inserted from the outside inwards.

The National Institute for Health and Care Excellence (NICE) is examining translaryngeal tracheostomy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about translaryngeal tracheostomy.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 27 May 2013

Target date for publication of guidance: 28 August 2013

1                      Provisional recommendations

1.1                  The evidence on the efficacy and safety of translaryngeal tracheostomy is adequate for use with normal arrangements for clinical governance, consent and audit.

1.2                  Clinicians wishing to undertake translaryngeal tracheostomy should receive specific training and should be experienced in using the procedure as carrying it out safely requires different skills to other methods of percutaneous tracheostomy insertion.

2                      Indications and current treatments

2.1                  Tracheostomy is commonly carried out for patients in intensive care to maintain their airway, to remove excessive airway secretions and to enable them to be weaned from mechanical ventilation. Usually anaesthetists and intensive care physicians perform the procedure using a percutaneous technique, inserting a tube from the outside of the neck into the trachea, using various devices and commonly under endoscopic guidance.

2.2                  The translaryngeal tracheostomy technique may lead to lower rates of bleeding, trauma and infection to the tissues surrounding the insertion area, compared with surgical and other percutaneous techniques. It may also avoid damage to the posterior wall of the trachea and tracheal rings because of a lack of external compression during insertion.

3                      The procedure

3.1                  Translaryngeal tracheostomy is a method for inserting a tracheostomy tube using direct endoscopic visualisation. It is usually carried out with the patient under general anaesthesia with muscle relaxation. The patient lies supine with the head extended, and the endotracheal tube is partially withdrawn to allow an endoscope to be passed into the trachea. A small introducer needle is inserted percutaneously between the second and third tracheal rings and visualised endoscopically as it enters the trachea. A metal guide wire is then passed through this needle into the trachea and pulled upwards and out through the mouth. The existing tubes are then temporarily replaced with a narrower ventilation tube for the remainder of the procedure. There are variations in this part of the technique: for example the guide wire may be fed through the distal end of the endotracheal tube or a rigid tracheoscope and recovered at the tube connector.

3.2              The guide wire is attached to a special tracheostomy device consisting of a flexible plastic cone with a pointed metal tip, joined to an armoured tracheal cannula. The tracheostomy device is then drawn back through, in turn, the oral cavity, the oropharynx, the larynx, the trachea and finally out to the surface of the neck, through the small stoma created by the introducer needle. Traction is applied to the guide wire with one hand, and counter pressure to the neck with the other hand. The cone is then separated from the tracheostomy tube which is rotated 180 degrees so the open end of the tube faces down towards the carina and bronchi. Correct placement of the tracheostomy tube is confirmed by auscultation of the lungs and endoscopy.

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

4.1                  A case series of 245 patients undergoing translaryngeal tracheostomy reported successful insertion in 99.2% (243 of 245) patients.

4.2                  A randomised controlled trial (RCT) of 100 patients comparing translaryngeal tracheostomy against forceps dilatation tracheostomy reported a significant decrease in post-procedural partial pressure of oxygen in blood (PaO₂) in the translaryngeal tracheostomy group (from 311 to 261 mmHg; p=0.0069) but not in the forceps dilatation tracheostomy group (from 289 to 284 mmHg; not significant). A significant increase in partial pressure of carbon dioxide in blood (PaCO₂) (p<0.001) and a decrease in arterial pH (p<0.001) was reported between pre and post-procedure blood gas analysis in both groups.

4.3                  A prospective comparative study of 100 patients comparing translaryngeal tracheostomy (n=50) against guide wire dilating forceps tracheostomy (n=50) reported that patients in the translaryngeal tracheostomy group needed a significantly higher fraction of inspired oxygen (FiO₂) to maintain SaO₂ above 92% after the procedure. FiO₂ levels increased from 0.52 to 0.62 [p<0.05] and 0.58 to 0.63 [not significant] in the translaryngeal tracheostomy and guide wire dilating forceps groups respectively. Deterioration of gas exchange was slight and temporary in both groups and no patient became hypoxic.

4.4                  An RCT of 139 patients comparing translaryngeal tracheostomy (n=67) against surgical tracheostomy (n=72) reported no significant differences in quality of life between the groups (assessed in 31 patients using SF-12 Health Survey questionnaire) at 1-year follow-up.

4.5                  The Specialist Advisers listed key efficacy outcomes as reduced trauma, bleeding and infection, good cosmetic outcome, and technical suitability in patients with coagulopathy or those with neck masses or altered tracheal anatomy, compared with surgical or other methods of percutaneous tracheostomy.

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

5.1                  Massive oropharyngeal haemorrhage due to an erosive lesion in the dorsal wall of the brachiocephalic artery was reported in a single case report 6 days after translaryngeal tracheostomy. After bleeding had been controlled a ‘conventional’ tracheostomy was performed.

5.2                  A 4 cm perforation of the posterior tracheal wall with severe damage to the second and third tracheal rings and massive subcutaneous emphysema occurred during 180-degree rotation of the tube in 1 patient in the translaryngeal tracheostomy group in the comparative study of 100 patients. An emergency surgical tracheostomy was performed. Lateral tracheal wall lesions caused during the 180-degree rotation of the cannula were reported in 3 patients in a case series of 470 patients; 1 needed thoracotomy to suture the defect. Another 2 patients had a mobile flap on the posterior tracheal wall, which was treated by laser therapy.

5.3                  Narrowing of the tube lumen because of severe crust formation despite ventilator humidification was reported in 19 patients in a subgroup of 24 patients who needed a first tracheal tube change by post-operative day 6 in a case series of 145 patients.

5.4                  Embedding of the translaryngeal tracheostomy tube because of stenosis of the tracheostomy opening was reported in 6 patients with long-term tracheostomies cared for at home. This was treated by surgical replacement of the tracheostomy tubes.

5.5                  Loss of the airway causing hypoxia was reported in 6% (3/47) of patients in the translaryngeal tracheostomy group in the RCT of 100 patients because of difficulties re-intubating patients with the narrower type of endotracheal tube.

5.6                  Stomal infection was reported in 3% (2/67) of patients in the translaryngeal tracheostomy group in the RCT of 139 patients.

5.7                  Several studies reported technical difficulties in placing the tracheostomy tube correctly. The tube was accidentally pulled completely out of the neck in 9 patients in the case series of 145. In 6 of these patients a second attempt at tube placement by a more experienced physician was successful; the other 3 patients were converted to surgical tracheostomy. The RCT of 100 patients reported problems with tube placement in 23% (11/47) of patients. These included the guide wire breaking in 3 patients and difficult retrograde passage of the guide wire in 3 patients. Other technical difficulties reported were fracture of the guide wire during traction in 0.6% of patients (2/350) in the case series of 470, dislocation of the tube in 4% (3/67) of patients in the RCT of 139, and displacement of the tube in 1% (2/145) of patients in the case series of 145.

5.8                  The Specialist Advisers listed anecdotal adverse events as directional misplacement of tube, difficulty in delivering the tube through the larynx, pneumothorax and airway obstruction by the device. Theoretical adverse events reported by the Specialist Advisers were: damage to recurrent laryngeal nerve, and thyroid injury.

6                      Committee comments

6.1                  The Committee was advised that the tracheostomy tubes designed to be inserted by this procedure may become blocked for reasons including contact with the posterior tracheal wall and difficulties with tracheal suctioning because of the shape of the tube.

6.2                  The Committee was also advised that the tubes cannot readily be replaced and are not suitable for patients who need long-term airway management.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

April 2013

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