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

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy
• Intervention / Treatment: Other: control; Device: Shiley™ phonate speaking valve

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ra'anana, Israel
    • Recruiting
    • Loewenstein Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: speaking valve; Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).	Device: Shiley™ phonate speaking valve; The device connects to the tracheostomy tube. Usually used to aid vocalization.; Other Names: speaking valve
Other: control; Respiratory physical therapy treatments conducted without using a speaking valve .	Other: control; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline oxygen saturation	at physical therapy sessions	15 minutes
change from baseline breathing rate	at physical therapy sessions	15 minutes

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of desaturation events	oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions.	2 weeks
number of respiratory physical therapy sessions	the number of respiratory physical therapy sessions given to a participant	2 weeks

Collaborators and Investigators

• Sponsor: Loewenstein Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0027-21-LOE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes