Laryngectomy; Status, Oropharyngeal Dysphagia
Conditions
Keywords
Dysphagia, Oropharyngeal dysphagia, Total Laryngectomy, Video Fluoroscopic Swallowing Exam (VFSE)
Brief summary
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
Detailed description
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.
Interventions
DEVICEContinuous Positive Airway Pressure
Apex XT Fit CPAP Machine
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 2 months after total laryngectomy * Undergoing Video Fluoroscopic Swallowing Examination
Exclusion criteria
* Patients with 100% neopharyngeal stenosis * Patients with active cancer within 2 months of the study * Patients with pharyngocutaneous fistula * Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Pharyngeal Transit Time (With CPAP) | During VFSE (1 day) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continue Positive Airway Pressure Continue Positive Airway Pressure during VFSE
Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Continue Positive Airway Pressure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
| Total Pharyngeal Transit Time @ Baseline (No CPAP) | 26.88 seconds STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: During VFSE (1 day)
Population: The total pharyngeal transit time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continue Positive Airway Pressure | Total Pharyngeal Transit Time (With CPAP) | 10.18 seconds | Standard Deviation 8.5 |
Comparison: The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAPp-value: <0.05ANOVA