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

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

Tracking Information

• First Submitted Date: July 25, 2022
• First Posted Date: August 1, 2022
• Last Update Posted Date: March 9, 2023
• Actual Study Start Date: August 1, 2022
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 28, 2022)

• change from baseline oxygen saturation [ Time Frame: 15 minutes ]
  at physical therapy sessions
• change from baseline breathing rate [ Time Frame: 15 minutes ]
  at physical therapy sessions

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 28, 2022)

• rate of swallowing [ Time Frame: 15 minutes ]
  during a physical therapy session
• percentage of participants presenting vocalization [ Time Frame: 2 weeks ]
  occurrence of vocalization at the respiratory physical therapy sessions.
• cough rate [ Time Frame: 2 weeks ]
  the ratio of respiratory physical therapy sessions eliciting cough.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 28, 2022)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
• Official Title: Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Tracheostomy

Intervention

• Device: Shiley™ phonate speaking valve
  The device connects to the tracheostomy tube. Usually used to aid vocalization.
  Other Name: speaking valve
• Other: control
  no intervention

Study Arms

• Experimental: speaking valve
  Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments).
  Intervention: Device: Shiley™ phonate speaking valve
• control
  Respiratory physical therapy treatments conducted without using a speaking valve .
  Intervention: Other: control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 28, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility 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%.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT05482022
• Other Study ID Numbers: 0027-21-LOE
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: elena eidinov, Loewenstein Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Loewenstein Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Loewenstein Hospital
• Verification Date: March 2023