NCT03008174

Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Completed NA Results posted Last updated 23 January 2020

What this trial tests

NA trial testing Early one-way speaking valve (OWSV) assessment in Respiratory Failure in 20 participants. Completed in 5 December 2019.

Timeline

5 February 2016

Primary endpoint
28 November 2019

5 December 2019

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	5 February 2016
Primary completion	28 November 2019
Estimated completion	5 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Early one-way speaking valve (OWSV) assessment

Conditions studied

• Respiratory Failure — all drugs for Respiratory Failure →
• Speech — all drugs for Speech →
• Aphonia — all drugs for Aphonia →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Respiratory Failure or Speech. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Speech Intelligibility as Assessed by Speech Intelligibility Test Score Primary · Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Group	Value	95% CI
Intervention	25.71	± 33.35
Control	0	± 0

Speech Intelligibility as Assessed by Speech Intelligibility Test Score Primary · Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Group	Value	95% CI
Intervention	13	± 26.46
Control	33.63	± 33.12

Speech Intelligibility as Assessed by Speech Intelligibility Test Score Primary · Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Group	Value	95% CI
Intervention	74.54	± 21.03
Control	35.97	± 39.5

Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores Secondary · Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)

Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

Group	Value	95% CI
Intervention	42.0	± 18.0
Control	41.7	± 13.4

Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores Secondary · Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)

Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

Group	Value	95% CI
Intervention	53.1	± 24.8
Control	47.3	± 12.8

Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores Secondary · Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

Group	Value	95% CI
Intervention	55.0	± 22.0
Control	47.1	± 16.2

Number of Participants With Bleeding Secondary · At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure

Bleeding will be reported as present or absent.

Group	Value	95% CI
Intervention	0
Control	0

Number of Participants With Bleeding Secondary · At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure

Bleeding will be reported as present or absent.

Group	Value	95% CI
Intervention	0
Control	0

Number of Participants With Bleeding Secondary · At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure

Bleeding will be reported as present or absent.

Group	Value	95% CI
Intervention	0
Control	0

Intensive Care Unit (ICU) Length of Stay Secondary · At the time of discharge, up to 4 months

ICU length of stay will be reported in days.

Group	Value	95% CI
Intervention	51	± 30.37
Control	53.9	± 51.46

Hospital Length of Stay Secondary · At the time of discharge, up to 4 months

Hospital length of stay will be reported in days.

Group	Value	95% CI
Intervention	69.7	± 33.86
Control	75.6	± 101.12

Sponsor's own description

Patients with tracheostomy who are on and off of mechanical ventilation initially lose the ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring speech in these patients. Patients with tracheostomy who experience loss of speech report frustration and feelings of confinement from patients' communication impairment, therefore investigators would like to restore speech in these patients as soon as it is safe to do so. However, there is currently little known in the literature about the timing of the use of OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test clinical trial pilot study to investigate the safety of early use of OWSV in patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit from the early use of OWSV and to determine the effects of early use of OWSV on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will be screened, and patients meeting screening criteria will be randomized into intervention and control groups. The intervention group will receive early speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will been compared on speech and clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test at 48-60 hours following tracheostomy and characteristics of patients who successfully tolerate early OWSV use will be identified.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Standard versus Accelerated Speaking Valve Placement after Percutaneous Tracheostomy: A Randomized Controlled Feasibility Study.
   Martin KA, Cole TDK, Percha CM, Asanuma N, et al · · 2021 · cited 21× · PMID 33760713 · DOI 10.1513/annalsats.202010-1282oc
2. Interindividual variability in the benefits of personal sound amplification products on speech perception in noise: A randomized cross-over clinical trial.
   Perron M, Lau B, Alain C. · · 2023 · cited 4× · PMID 37467243 · DOI 10.1371/journal.pone.0288434
3. Rapid Brain Adaptation to Hearing Amplification: A Randomized Crossover Trial of Personal Sound Amplification Products.
   Perron M, Dimitrijevic A, Alain C. · · 2025 · PMID 40910451 · DOI 10.1177/23312165251375891