Tracheostomy
Conditions
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.
Interventions
DEVICEShiley™ phonate speaking valve
The device connects to the tracheostomy tube. Usually used to aid vocalization.
OTHERcontrol
no intervention
Sponsors
Loewenstein Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline oxygen saturation | 15 minutes | at physical therapy sessions |
| change from baseline breathing rate | 15 minutes | at physical therapy sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of participants presenting vocalization | 2 weeks | occurrence of vocalization at the respiratory physical therapy sessions. |
| percentage of patients weaned from tracheostomy | through study completion, an average of 6 months. | whether or not decannulation was successfully performed during rehabilitation. |
| cough rate | 2 weeks | the ratio of respiratory physical therapy sessions eliciting cough. |
| rate of swallowing | 15 minutes | during a physical therapy session |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of respiratory physical therapy sessions | 2 weeks | the number of respiratory physical therapy sessions given to a participant |
| number of desaturation events | 2 weeks | oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions. |
Countries
Israel
Contacts
Primary ContactElena Aidinoff, MD
Outcome results
None listed