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

Tracheostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482022
• Other study ID #: 0027-21-LOE
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2023
• Source: Loewenstein Hospital
• Contact: Elena Aidinoff, MD
• Phone: 972-9-7654897
• Email: aidinofe[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Tracheostomy

Intervention

Device:
• Shiley™ phonate speaking valve
The device connects to the tracheostomy tube. Usually used to aid vocalization.

Other:
• control
no intervention

Locations

Country	Name	City	State
Israel	Loewenstein Rehabilitation Hospital	Ra'anana

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of desaturation events	oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions.	2 weeks
Other	number of respiratory physical therapy sessions	the number of respiratory physical therapy sessions given to a participant	2 weeks
Primary	change from baseline oxygen saturation	at physical therapy sessions	15 minutes
Primary	change from baseline breathing rate	at physical therapy sessions	15 minutes
Secondary	rate of swallowing	during a physical therapy session	15 minutes
Secondary	percentage of participants presenting vocalization	occurrence of vocalization at the respiratory physical therapy sessions.	2 weeks
Secondary	cough rate	the ratio of respiratory physical therapy sessions eliciting cough.	2 weeks
Secondary	percentage of patients weaned from tracheostomy	whether or not decannulation was successfully performed during rehabilitation.	through study completion, an average of 6 months.