Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Johns Hopkins University

Status: Completed

Conditions: Respiratory Failure; Speech; Aphonia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03008174

IRB00080981

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

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

Control

No Intervention group

Description:

1. Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. 2. Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.