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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Shiley™ phonate speaking valve
DeviceThe device connects to the tracheostomy tube. Usually used to aid vocalization.
control
Other interventionno intervention
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: speaking valveExperimental treatment 1 intervention
Group B: controlOther 1 intervention
Trial outcomes
Primary outcomes
1
change from baseline oxygen saturation
at physical therapy sessions
Time frame
15 minutes2
change from baseline breathing rate
at physical therapy sessions
Time frame
15 minutesSecondary outcomes
1
rate of swallowing
during a physical therapy session
Time frame
15 minutes2
percentage of participants presenting vocalization
occurrence of vocalization at the respiratory physical therapy sessions.
Time frame
2 weeks3
cough rate
the ratio of respiratory physical therapy sessions eliciting cough.
Time frame
2 weeks4
percentage of patients weaned from tracheostomy
whether or not decannulation was successfully performed during rehabilitation.
Time frame
through study completion, an average of 6 months.Other outcomes
1
number of desaturation events
oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions.
Time frame
2 weeks2
number of respiratory physical therapy sessions
the number of respiratory physical therapy sessions given to a participant
Time frame
2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov