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 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° rotation of the tube in 1 patient in the translaryngeal tracheostomy group in a comparative study of 100 patients comparing translaryngeal tracheostomy (n=50) against guide wire dilating forceps tracheostomy (n=50). An emergency surgical tracheostomy was performed. Lateral tracheal wall lesions caused during the 180° rotation of the cannula were reported in 3 patients in a case series of 470 patients; 1 needed thoracotomy to suture the defect, the other 2 patients were treated with laser therapy.
5.3 Loss of the airway causing hypoxia was reported in 6% (3/47) of patients in the translaryngeal tracheostomy group in a randomised controlled trial (RCT) of 100 patients comparing translaryngeal tracheostomy against forceps dilatation tracheostomy because of difficulties re‑intubating patients with the narrower type of endotracheal tube.
5.4 Stomal infection was reported in 3% (2/67) of patients in the translaryngeal tracheostomy group in the RCT of 139 patients.
5.5 The tube was accidentally pulled completely out of the neck during insertion in 9 patients in a case series of 145. 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.
5.6 The RCT of 100 patients reported a significant decrease in post‑procedural partial pressure of oxygen in blood 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).
5.7 The specialist advisers listed anecdotal adverse events as directional misplacement of tube, dislocation of the 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 the recurrent laryngeal nerve, and thyroid injury.