Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy
Phase: NA
Conditions: Oropharyngeal Dysphagia, Laryngectomy; Status
Sponsor: University of California, Davis

Official Title of Study: CPAP to Improve Swallow Function Post Total Laryngectomy 
NCT# 03328702 
Document Date May 20, 2016 
Attached is the UC Davis IRB approved Protocol and there have been no protocol changes 
since 2016. 
Sincerely, 
Peter C. Belafsky, M.D., M.P.H., Ph.D. 
Department of Otolaryngology Head and Neck Surgery 
University of California, Davis School of Medicine 

PROTOCOL TITLE: Utilization of Continuous Positive Airway Pressure 
to Improve Swallow Function in Patients Post Total Laryngectomy  
 
Page 1 of 5 
 
Revised: February 9, 2016 
1) 
Protocol Title 
Utilization of Continuous Positive Airway Pressure to Improve 
Swallow Function in Patients Post Total Laryngectomy  
Version date: 5.3.16 
 
2) 
Objectives 
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.  
 
3) 
Background 
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. These difficulties can result 
from pharyngeal neuromuscular damage caused by surgery and 
radiation (1). Previous research has demonstrated a reduction in 
pharyngeal contractile pressure and increased pharyngeal transit 
time in patients post laryngectomy (2,3).  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 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. 

PROTOCOL TITLE: Utilization of Continuous Positive Airway Pressure 
to Improve Swallow Function in Patients Post Total Laryngectomy  
 
Page 2 of 5 
 
Revised: February 9, 2016 
4) 
Inclusion and Exclusion Criteria 
Inclusion criteria: 
- Age ≥18 years.  
- Patients at least 2 months after total laryngectomy undergoing a 
dynamic swallow study (DSS).  
 
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 
• Individuals who are not yet adults (infants, children, 
teenagers) 
• Pregnant women 
• Prisoners 
 
5) 
Study Timelines 
The subjects will be in study from the time they sign the consent form 
to completion of the videofluoroscopy study. Approximately 5 
additional minutes will be added to each subject’s clinical DSS study, 
with no more than 1-2 seconds of additional fluoroscopic exposure  
The estimated date of complete of the study will be 12 months after 
IRB approval.  
 
6) 
Study Endpoints 
Primary endpoint of the study is complete videofluoroscopic data for all 
10 patients. 
 
7) 
Procedures Involved 
Each subject will undergo a standard DSS for the purpose of medical 
diagnosis. The research study portion will be incorporated into the 
procedure for patients who consent to participation in the study. The 
dynamic swallow study is a radiologic examination 
of swallowing function using fluoroscopy. Standard examinations 
consist of multiple radio-opaque boluses of different consistencies. 
During a standard videofluoroscopic study, subject are asked to 

PROTOCOL TITLE: Utilization of Continuous Positive Airway Pressure 
to Improve Swallow Function in Patients Post Total Laryngectomy  
 
Page 3 of 5 
 
Revised: February 9, 2016 
swallow barium-coated foods of the following volumes and 
consistencies in side and front view. Swallows can be added to the 
protocol in order to assess clinical questions relevant to each specific 
patient. 
 
Lateral Plane 
• 1 ml liquid barium (X2) 
• 20 ml liquid barium (X2) 
• 60 ml thin liquid barium consecutive sips via straw  
• 3 ml pudding  
 
Anterior-to-Posterior Plane 
• 20 ml liquid barium  
• 13 mm barium tablet  
 
In order to minimize exposing participants to additional 
radiation during this this study, the patients will be asked to 
wear the CPAP mask during standard swallows test for one of 
the two swallows of the following consistencies in side view: 
• 1 ml thin liquid barium  
• 20 ml thin liquid barium 
 
One additional 3ml pudding bolus swallow with the CPAP mask will be 
added in order to compare swallow function of a pudding consistency with 
and without the CPAP. This additional swallow will add no more than 1-2 
seconds of videofluoroscopic exposure time.  
 
8) 
Data and/or Specimen Management and Confidentiality 
The measures explained in the online application will be taken to 
protect the confidentiality of subjects: 
 
Videofluoroscopic data collected from the above protocol will be 
analyzed by paired sample T test and repeated measures of analysis of 
variance.  Data will be stored anonymously and securely, accessible 
with a password available only to participating researchers. 
 
9) 
Data and/or Specimen Banking 
N/A 

PROTOCOL TITLE: Utilization of Continuous Positive Airway Pressure 
to Improve Swallow Function in Patients Post Total Laryngectomy  
 
Page 4 of 5 
 
Revised: February 9, 2016 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A. This study does not pose more than a minimal risk to subjects. 
 
11) Withdrawal of Subjects 
Subjects unable to complete the entire protocol may be withdrawn from 
the study and not included in data analysis. 
 
12) Risks to Subjects 
Patients are undergoing the videofluoroscopic procedure as standard of 
care. One additional swallow will be added to the standard protocol, 
adding a minimal 1-2 seconds of fluoroscopic exposure time.  
 
 
 
The risks of the CPAP device include skin irritation, dry mouth, nasal 
congestion. These risks are unlikely to occur during this study in which 
patients will be wearing the mask for only several minutes. Subjects 
may experience stomach bloating. Subjects may experience discomfort 
from wearing the mask. 
 
13) Potential Benefits to Subjects 
No direct benefit to participating subjects is anticipated. 
 
14) Multi-Site Research 
N/A 
 
15) Sharing of Results with Subjects 
Results will not be shared with subjects.  
16) Prior Approvals 
Radiation Use Committee approval was obtained before IRB 
submission 
17) Provisions to Protect the Privacy Interests of Subjects 
Subjects will undergo the protocol privately with a limited 
number of qualified personnel present.  Beyond determining 
eligibility as described above, no personal or medical 
information will be sought from participants.  The procedure 
will be limited to only what is described in the above protocol. 
Only qualified research personnel working on the project will 
access subjects’ secure data, which will be password-protected. 

PROTOCOL TITLE: Utilization of Continuous Positive Airway Pressure 
to Improve Swallow Function in Patients Post Total Laryngectomy  
 
Page 5 of 5 
 
Revised: February 9, 2016 
18) Compensation for Research-Related Injury 
N/A. The study procedure does not pose more than minimal risk to 
subjects. 
19) Economic Burden to Subjects 
N/A  
 
20) Drugs or Devices 
N/A 
 
References 
 1.  
Zhang T, Szczesniak M, Maclean J, Bertrand P, Wu PI, Omari T, et 
al. Biomechanics of Pharyngeal Deglutitive Function Following Total 
Laryngectomy. Otolaryngol--Head Neck Surg Off J Am Acad Otolaryngol-
Head Neck Surg. 2016 Apr 26;  
2.  
McConnel FM, Mendelsohn MS, Logemann JA. Manofluorography 
of deglutition after supraglottic laryngectomy. Head Neck Surg. 1987 
Feb;9(3):142–50.  
3.  
McConnel FM, Cerenko D, Mendelsohn MS. Dysphagia after total 
laryngectomy. Otolaryngol Clin North Am. 1988 Nov;21(4):721–6.