Dosemeci 2002

Methods	This randomized, parallel‐group study was conducted at a single centre in Turkey
Participants	Investigators recruited 60 participants (30 in the ETT group; 30 in the LMA group) of both genders, 17 to 84 years of age, who required elective tracheostomy. Main indications for tracheostomy were prolonged endotracheal intubation and neurological impairment with an inability to protect the airway Demographics of included participants 20 men and 10 women in ETT group; 19 men and 7 women in LMA group Mean age (range) in intervention group = 42.1 ± 22.4 years (17 to 84 years) Mean age (range) in control group = 47.1 ± 15 years (18 to 74 years) Disease status: head injury: LMA group n = 8; ETT group n = 7; neurological disease: LMA group n = 6; ETT group n = 9; multi‐trauma: LMA group n = 5; ETT group n = 3; sepsis and ARF: LMA group n = 4; ETT group n = 7; COPD: LMA group n = 3; ETT group n = 4 Exclusion criteria of the trial Difficult tracheal intubation Suspected pathology of the pharynx Recent local radiation of the upper airway Significant infection of the upper airway
Interventions	In the intervention group, ETT was removed and was replaced with LMA In the control group, the cuff of the ETT was deflated and was withdrawn until the cuff was visible at the vocal cords. The cuff was reinflated Nasogastric tube was suctioned and was left in place during the procedure
Outcomes	Procedure‐related mortality Serious adverse events: non‐fatal loss of airway, puncture of ETT cuff, extubation, tracheal stenosis, bleeding, difficult insertion of tracheostomy tube Duration of procedure Failure of procedure requiring conversion to any other procedure
Notes	Funding body was not declared Abbreviations: ARF: acute respiratory failure COPD: chronic obstructive pulmonary disease ETT: endotracheal tube LMA: laryngeal mask airway PDT: percutaneous dilatational tracheostomy PEEP: positive end‐expiratory pressure
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study authors did not provide information about this. We sought information but received no response
Allocation concealment (selection bias)	Unclear risk	Study authors did not provide information about this. We sought information but received no response
Incomplete outcome data (attrition bias) All outcomes	High risk	4 participants were lost to follow‐up (4/30 = 13.3% in the intervention group, resulting in 56 participants evaluated (26 in the intervention group and 30 in the control group)) 2 participants (6.7%) dropped out because LMA could not be inserted. These events were not analysed in the LMA group as adverse outcomes
Selective reporting (reporting bias)	Unclear risk	We contacted the corresponding author for additional outcome data but received no response within the time limit
Other bias	Unclear risk	It was not stated how the trial was funded. No significant differences between ETT and LMA groups were noted in baseline characteristics of participants
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants were sedated with midazolam
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It was not stated whether outcome assessors were blinded