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Investigator initiated prospective study to determine whether use of Continuous Positive Airway Pressure (CPAP) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing
Total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. The procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. Following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. Previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. Continuous Positive Airway Pressure (CPAP) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. This study aims to evaluate the utility of a CPAP mask to improve pharyngeal swallow outcomes during Video Fluoroscopic Swallowing Exam (VFSE) in patients with dysphagia following total laryngectomy. This specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue Positive Airway Pressure | Experimental | Continue Positive Airway Pressure during VFSE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | Apex XT Fit CPAP Machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Pharyngeal Transit Time (With CPAP) | This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure. | During VFSE (1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continue Positive Airway Pressure | Continue Positive Airway Pressure during VFSE Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continue Positive Airway Pressure | Continue Positive Airway Pressure during VFSE Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Pharyngeal Transit Time (With CPAP) | This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure. | The total pharyngeal transit time | Posted | Mean | Standard Deviation | seconds | During VFSE (1 day) |
|
|
20 minutes (the approximate duration of the fluoroscopic swallow study).
There were no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continue Positive Airway Pressure | Continue Positive Airway Pressure during VFSE Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Belafsky | University of California, Davis | 8582053366 | pcbelafsky@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2016 | Dec 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Total Pharyngeal Transit Time @ Baseline (No CPAP) | Mean | Standard Deviation | seconds |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D010038 | Otorhinolaryngologic Diseases |
| D012138 |
| Respiratory Therapy |