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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| speaking valve | Experimental | Respiratory physical therapy treatments conducted using a speaking valve for 2 weeks (at least 8 treatments). |
|
| control | Other | Respiratory physical therapy treatments conducted without using a speaking valve . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shileyâ„¢ phonate speaking valve | Device | The device connects to the tracheostomy tube. Usually used to aid vocalization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline oxygen saturation | at physical therapy sessions | 15 minutes |
| change from baseline breathing rate | at physical therapy sessions | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| rate of swallowing | during a physical therapy session | 15 minutes |
| percentage of participants presenting vocalization | occurrence of vocalization at the respiratory physical therapy sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| number of desaturation events | oxygen levels decrease below 90% or by 3% from baseline during respiratory physical therapy sessions. | 2 weeks |
| number of respiratory physical therapy sessions | the number of respiratory physical therapy sessions given to a participant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Aidinoff, MD | Contact | 972-9-7654897 | aidinofe@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loewenstein Rehabilitation Hospital | Recruiting | Raanana | Israel |
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| control | Other | no intervention |
|
| 2 weeks |
| cough rate | the ratio of respiratory physical therapy sessions eliciting cough. | 2 weeks |
| percentage of patients weaned from tracheostomy | whether or not decannulation was successfully performed during rehabilitation. | through study completion, an average of 6 months. |
| 2 weeks |