Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Completed · Not applicable

Conditions studied: Respiratory Failure, Speech, Aphonia

In brief

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.

Key facts

Study ID

NCT03008174

Run by

Johns Hopkins University

People needed

20

Starts

2016-02-05

Expected to finish

2019-12-05

Last updated by the study team

2020-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient who received a percutaneous tracheostomy
• Glasgow Coma Scale score ≥9
• Confusion Assessment Method -ICU (CAM-ICU): negative
• Richmond Agitation Sedation Scale (RASS): -1 to +1
• Able to understand English

You may not qualify if…

• Open tracheostomy
• Laryngectomy
• Presently using OWSV or capped trach
• Foam-filled cuffed tracheostomy tube
• Presence of known severe airway obstruction
• Presence of post-operative bleeding requiring transfusion or packing
• Presence of air-leak around the cuff resulting in respiratory decompensation

Where it is running

• The Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.