Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2026
CompletedAugust 14, 2025
August 1, 2025
2.7 years
July 25, 2022
August 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
change from baseline oxygen saturation
at physical therapy sessions
15 minutes
change from baseline breathing rate
at physical therapy sessions
15 minutes
Secondary Outcomes (4)
rate of swallowing
15 minutes
percentage of participants presenting vocalization
2 weeks
cough rate
2 weeks
percentage of patients weaned from tracheostomy
through study completion, an average of 6 months.
Other Outcomes (2)
number of desaturation events
2 weeks
number of respiratory physical therapy sessions
2 weeks
Study Arms (2)
speaking valve
EXPERIMENTALRespiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).
control
OTHERRespiratory physical therapy treatments conducted without using a speaking valve .
Interventions
The device connects to the tracheostomy tube. Usually used to aid vocalization.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- airway stenosis / inflammation.
- oxygen saturation \<90%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loewenstein Rehabilitation Hospital
Raanana, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Intensive Care for Consciousness Rehabilitation Department
Study Record Dates
First Submitted
July 25, 2022
First Posted
August 1, 2022
Study Start
August 1, 2022
Primary Completion
March 27, 2025
Study Completion
January 15, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share