title: Return of Voice for Ventilated Tracheostomy Patients in ICU: A Randomized Controlled Trial of Early-Targeted Intervention.
abstract: OBJECTIVE
  A cuffed tracheostomy tube facilitates prolonged mechanical ventilation and weaning but usually leads to prolonged voicelessness, which can be one of the most negative experiences of hospitalization. No randomized trials have examined the effects of targeted early communication intervention for the restoration of voice in ventilated tracheostomy patients in the ICU.
  
  
  METHODS
  A prospective randomized clinical trial.
  
  
  METHODS
  The trial was conducted in the ICU of an urban tertiary level hospital.
  
  
  METHODS
  Thirty adult participants enrolled, with 15 randomly allocated to the intervention and control groups.
  
  
  METHODS
  The early intervention group received early cuff deflation and insertion of an in-line speaking valve during mechanical ventilation. The control group received standard cuff deflation and a speaking valve during self-ventilation. A speech-language pathologist provided all treatments.
  
  
  RESULTS
  The primary outcome measure was time from tracheostomy insertion to phonation. Early intervention significantly hastened return to phonation (median difference = 11 d; hazard ratio = 3.66; 95% CI, 1.54-8.68) with no significant effect on duration of tracheostomy cannulation (hazard ratio = 1.40; 95% CI, 0.65-3.03), duration of mechanical ventilation in days from tracheostomy insertion (hazard ratio = 1.19; 95% CI, 0.58-2.51), length of stay in ICU (hazard ratio = 1.16; 95% CI, 0.54-2.52), or time to return to oral intake (hazard ratio = 2.35; 95% CI, 0.79-6.98). Adverse events were low and equal in both groups. There was no significant change in measures of quality of life.
  
  
  CONCLUSIONS
  Focused early intervention for communication during mechanical ventilation allows the restoration of phonation significantly sooner than standard treatment, with no increase in complications in a small patient cohort. Although these results are favorable, further research is needed to determine whether the effects on any of the secondary outcomes are statistically significant and clinically important.
authors: 1Department of Speech Pathology, Royal Prince Alfred Hospital, Sydney, NSW, Australia. 2Department of Speech Pathology, Faculty of Health Sciences, University of Sydney, Sydney, Australia. 3National Health and Medical Research Council Centre of Research Excellence in Brain Recovery, Sydney, NSW, Australia. 4Sydney Medical School, Faculty of Medicine, University of Sydney, Sydney, Australia. 5Department of Intensive Care, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
authors: Amy L
authors: AL
authors: Freeman-Sanderson
authors: Leanne
authors: L
authors: Togher
authors: Mark R
authors: MR
authors: Elkins
authors: Paul R
authors: PR
authors: Phipps
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010699:Phonation; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012121:Respiration, Artificial / Q000009:adverse effects* / Q000295:instrumentation; D013064:Speech Disorders / Q000209:etiology* / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D014139:Tracheostomy / Q000009:adverse effects* / Q000379:methods