Recruiting NCT05482022
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shiley™ phonate speaking valve, control.
- Who it may be relevant to
- Registry conditions: Tracheostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Shiley™ phonate speaking valve
The device connects to the tracheostomy tube. Usually used to aid vocalization. - Other control
no intervention
Primary outcome measures
- change from baseline oxygen saturation [Time frame: 15 minutes]
- change from baseline breathing rate [Time frame: 15 minutes]
Secondary outcome measures (4)
- rate of swallowing [Time frame: 15 minutes]
- percentage of participants presenting vocalization [Time frame: 2 weeks]
- cough rate [Time frame: 2 weeks]
- percentage of patients weaned from tracheostomy [Time frame: through study completion, an average of 6 months.]
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%.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Israel · 1 center
- Loewenstein Rehabilitation Hospital — Raanana
Identifiers
NCT: NCT05482022 · 0027-21-LOE