Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Not Applicable

Completed

Conditions: Aphonia
Respiratory Failure
Speech

Interventions: Other: Early one-way speaking valve (OWSV) assessment

Registration Number: NCT03008174

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Early one-way speaking valve (OWSV) assessment	1. Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure. 2. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. 3. Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.

Primary Outcome Measures

Name	Time	Method
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	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.
Number of Participants With Bleeding	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.
Intensive Care Unit (ICU) Length of Stay	At the time of discharge, up to 4 months	ICU length of stay will be reported in days.
Hospital Length of Stay	At the time of discharge, up to 4 months	Hospital length of stay will be reported in days.