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

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ClinicalTrials.gov Identifier: NCT05482022
Recruitment Status : Recruiting
First Posted : August 1, 2022
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
elena eidinov, Loewenstein Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Tracheostomy Device: Shiley™ phonate speaking valve Other: control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : March 2025
Arms and Interventions
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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 Name: speaking valve
control
Respiratory physical therapy treatments conducted without using a speaking valve .
 Other: control
no intervention


Outcome Measures
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Primary Outcome Measures :
  1. change from baseline oxygen saturation [ Time Frame: 15 minutes ]
    at physical therapy sessions

  2. change from baseline breathing rate [ Time Frame: 15 minutes ]
    at physical therapy sessions


Secondary Outcome Measures :
  1. rate of swallowing [ Time Frame: 15 minutes ]
    during a physical therapy session

  2. percentage of participants presenting vocalization [ Time Frame: 2 weeks ]
    occurrence of vocalization at the respiratory physical therapy sessions.

  3. cough rate [ Time Frame: 2 weeks ]
    the ratio of respiratory physical therapy sessions eliciting cough.

  4. percentage of patients weaned from tracheostomy [ Time Frame: through study completion, an average of 6 months. ]
    whether or not decannulation was successfully performed during rehabilitation.


Other Outcome Measures:
  1. number of desaturation events [ Time Frame: 2 weeks ]
    oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions.

  2. number of respiratory physical therapy sessions [ Time Frame: 2 weeks ]
    the number of respiratory physical therapy sessions given to a participant


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05482022


Contacts
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Contact: Elena Aidinoff, MD 972-9-7654897 aidinofe@clalit.org.il

Locations
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Israel
Loewenstein Rehabilitation Hospital Recruiting
Ra'anana, Israel
Contact: Sara Lipkin         
Sponsors and Collaborators
Loewenstein Hospital
More Information
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Responsible Party: elena eidinov, Head of Intensive Care for Consciousness Rehabilitation Department, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT05482022    
Other Study ID Numbers: 0027-21-LOE
First Posted: August 1, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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