Pandian 2020a.

Study characteristics
Methods	Parallel‐group randomised controlled trial
Participants	20 participants Inclusion criteria: received a percutaneous tracheostomy; GCS score ≥ 9; CAM‐ICU negative; RASS: –1 to +1; able to understand English. Exclusion criteria: open tracheostomy; laryngectomy; recently using 1‐way speaking valve or capped trach; foam‐filled cuffed tracheostomy tube; presence of known severe airway obstruction; presence of postoperative bleeding requiring transfusion or packing; presence of air‐leak around the cuff resulting in respiratory decompensation.
Interventions	Intervention Early 1‐way speaking valve assessment by SLP following 12–24 hours after percutaneous tracheostomy procedure. Second 1‐way speaking valve evaluation with SLP following 48–60 hours from initial percutaneous tracheostomy procedure. Third 1‐way speaking valve evaluation with SLP following first tracheostomy tube change. Participants were allowed additional SLP sessions between second and third sessions per standard of care. Control Standard 1‐way speaking valve evaluation with SLP following 48–60 hours from initial percutaneous tracheostomy procedure. Second 1‐way speaking valve evaluation with SLP following first tracheostomy tube change. Participants were allowed additional SLP sessions between first and second sessions per standard of care.
Outcomes	Speech intelligibility. Quality of life. Bleeding. ICU and hospital length of stay.
Notes	Results taken from those posted on ClinicalTrials.gov and communication with the study lead – publication anticipated in 2021.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not described. Information sought but not obtained.
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment not described. Information sought but not obtained.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind due to the nature of the intervention.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessors not described. Information sought but not obtained.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	7/20 (35%) participants did not complete third speech intelligibility test (primary outcome) but completed first and second test.
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias.
Other bias	Low risk	No evidence of other bias. Funding: none stated in results posted on ClinicalTrials.gov. Author conflict of interest: none stated.