Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Not Applicable

Recruiting

• Conditions: Tracheostomy
• Interventions: Other: control; Device: Shiley™ phonate speaking valve

• Registration Number: NCT05482022
• Lead Sponsor: Loewenstein Hospital

Brief Summary

Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.

The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-28
• Study Start: 2022-08-01
• Study First Posted: 2022-08-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• brain injury (traumatic/non-traumatic).
• tracheostomy.
• unresponsive wakefulness syndrome or minimally conscious state.
• fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.
• the legal guardian speaks Hebrew.

Exclusion Criteria

• airway stenosis / inflammation.
• oxygen saturation <90%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	Respiratory physical therapy treatments conducted without using a speaking valve .
speaking valve	Shiley™ phonate speaking valve	Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).

Primary Outcome Measures

Name	Time	Method
change from baseline oxygen saturation	15 minutes	at physical therapy sessions
change from baseline breathing rate	15 minutes	at physical therapy sessions

Secondary Outcome Measures

Name	Time	Method
percentage of participants presenting vocalization	2 weeks	occurrence of vocalization at the respiratory physical therapy sessions.
cough rate	2 weeks	the ratio of respiratory physical therapy sessions eliciting cough.
percentage of patients weaned from tracheostomy	through study completion, an average of 6 months.	whether or not decannulation was successfully performed during rehabilitation.
rate of swallowing	15 minutes	during a physical therapy session

Trial Locations

Locations (1)

Loewenstein Rehabilitation Hospital; 🇮🇱 Ra'anana, Israel