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RecruitingNot ApplicableNCT05482022

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

Sponsor

Loewenstein Hospital

Enrollment

30 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Tracheostomy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • airway stenosis / inflammation.
  • oxygen saturation \<90%.
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Interventions

DEVICEShiley™ phonate speaking valve

The device connects to the tracheostomy tube. Usually used to aid vocalization.

OTHERcontrol

no intervention

Locations(1)

Loewenstein Rehabilitation Hospital

Raanana, Israel

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NCT05482022

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