Pandian 2020b.

Study characteristics
Methods	Parallel‐group randomised controlled trial
Participants	50 participants Inclusion criteria: mechanically ventilated adults in ICU who were awake, alert, and attempting to communicate; English‐speaking; and unable to tolerate a 1‐way speaking valve on initial screening. Exclusion criteria: people who were delirious, had a tracheostomy within previous 48 hours, or a laryngectomy.
Interventions	Intervention BLUSA Talking tracheostomy that has an additional above cuff lumen. Participants received 3 treatment sessions from an SLP focusing on optimising voice – optimal airflow required communicate. Control Assessment by an SLP and provision of communication boards/i‐Pads.
Outcomes	Overall quality of life. Voice‐Related Quality of Life. Speech intelligibility. Independence. Satisfaction.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Implemented a computerised randomisation procedure using Excel 2016 (Microsoft Corp., Redmond, WA) by the primary investigator. Research ID numbers for 50 potential patients were randomly allocated to the control or intervention arm.
Allocation concealment (selection bias)	Low risk	Upon obtaining consent, based on the research identification number, the SLP was notified of the allocated arm for each patient by the primary investigator via e‐mail to ensure concealed allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind due to nature of the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unable to blind outcome assessors as could visualise the intervention when collecting outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No evidence of incomplete data.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting bias (trial registration checked).
Other bias	Low risk	No evidence of other bias. Funding: Smiths Medical Research Grant, Society of Otorhinolaryngology and Head‐Neck Nurses Research Grant, and the Johns Hopkins Shirley Sohmer Research Grant (not considered source of bias). Author conflict of interest: none stated.