Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
ConditionTracheostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoewenstein Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
airway stenosis / inflammation.
oxygen saturation <90%.
Trial design
Treatments tested in this trial
- Shiley™ phonate speaking valve
- control
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov