Objective: The primary objective of our study was to determine the quality of life (QOL) using a talking tracheostomy tube. Methods: Randomized clinical trial (NCT2018562). Adult intensive care unit patients who were mechanically ventilated, awake, alert, attempting to communicate, English-speaking, and could not tolerate one-way speaking valve were included. Intervention comprised a Blue Line Ultra Suctionaid (BLUSA) talking tracheostomy tube (Smiths Medical, Dublin, OH, US). Outcome measures included QOL scores measured using Quality of Life in Mechanically Ventilated Patients (QOL-MV) and Voice-Related Quality of Life (V-RQOL), Speech Intelligibility Test (SIT) scores, independence, and satisfaction.Results: The change in V-RQOL scores from pre-to postintervention was higher among patients using a BLUSA (Smiths Medical) compared to those who did not (P = 0.001). The QOL-MV scores from pre-to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04). SIT scores decreased by 6.4 points for each 1-point increase in their Sequential Organ Failure Assessment scores (P = 0.04). The overall QOL-MV scores correlated moderately with the overall V-RQOL scores (correlation coefficient = 0.59). Cronbach alpha score for overall QOL-MV was 0.71. Seventy-three percent of the 22 intervention patients reported the ability to use the BLUSA (Smiths Medical) with some level of independence, whereas 41% reported some level of satisfaction with the use of BLUSA (Smiths Medical). The lengths of stay was longer in the intervention group.Conclusion: Our study suggests that BLUSA (Smiths Medical) talking tracheostomy tube improves patient-reported QOL in mechanically ventilated patients with a tracheostomy who cannot tolerate cuff deflation.

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