Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Conditions: Spinal Cord Injuries, Deglutition Disorders
Sponsor: University Health Network, Toronto

Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
STUDY PROTOCOL 
Respiratory Capacity and Swallowing Function in Spinal Disorders:  
A Pilot Study 
 
PI: Catriona M. Steele, Ph.D. 
Swallowing Rehabilitation Research Laboratory 
Toronto Rehabilitation Institute – University Health Network
NCT 04114604 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
 
 
Table of Contents 
Introduction .................................................................................................................................................. 3 
Purpose and Specific Aims ............................................................................................................................ 3 
Methods ........................................................................................................................................................ 4 
Participants ............................................................................................................................................... 4 
Exclusion Criteria....................................................................................................................................... 4 
Recruitment .............................................................................................................................................. 5 
Stimuli ....................................................................................................................................................... 5 
Data to be Collected from each Participant .............................................................................................. 5 
Data Collection Procedures....................................................................................................................... 6 
Data Processing ......................................................................................................................................... 7 
Data Analysis ............................................................................................................................................. 8 
Risks and Benefits ......................................................................................................................................... 8 
Risks .......................................................................................................................................................... 8 
Benefits ..................................................................................................................................................... 9 
Privacy and Confidentiality ........................................................................................................................... 9 
Compensation ............................................................................................................................................. 10 
Transportation ............................................................................................................................................ 10 
Conflicts of Interest ..................................................................................................................................... 10 
Informed Consent Process .......................................................................................................................... 11 
Scholarly Review ......................................................................................................................................... 11 
Additional Ethics Reviews ........................................................................................................................... 11 
Contracts ..................................................................................................................................................... 11 
Budgets ....................................................................................................................................................... 11 
References .................................................................................................................................................. 12 
 
 
 
 
 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
Introduction 
This protocol covers a subproject formed from a larger project entitled Physiological Flow of 
Liquids Used in Dysphagia Management. The larger project has been reviewed and funded by 
the National Institutes of Health as a 5-year R01 grant awarded to the PI (Catriona Steele, Ph.D). 
 
The overall goal of the project is to collect measurements of liquid flow through the oropharynx 
(i.e., mouth and throat) during swallowing.  The factors that are expected to influence liquid 
flow include the liquid consistency (i.e., thin, slightly-thick, mildly-thick, moderately-thick, 
extremely thick) and the forces applied during swallowing (i.e., tongue pressures and 
swallowing muscle contraction).   The objective is to determine how these factors interact to 
influence the flow of a liquid through the oropharynx.  The focus of this project is to evaluate 
the flow of liquids of varying consistency in the spinal disorder population.  
 
Data collection will take place at the Swallowing Rehabilitation Research Lab of the Toronto 
Rehabilitation Institute. Videofluoroscopy x-rays will be conducted on a purchased service basis 
in the diagnostic imaging department at the Toronto General Hospital. Data will also be 
collected via patient-report questionnaires.   
Purpose and Specific Aims 
Spinal disorders are considered a wide class of diseases and/or injuries that challenge the 
stability and function of the spinal vertebrae, spinal column, and associated structures.  Spinal 
disorders can affect any level of the spine, resulting in a variety of sensory and motor 
impairments.  In approximately 10-15% of cases, spinal disorders have a known pathology, such 
as a congenital condition, traumatic injury, or tumor (Boos & Aebi, 2008). Structural or nerve 
damage related to the spinal disorder may contribute to an individual’s swallowing impairment.  
Three nerves with key functions in swallowing have been identified as susceptible to damage as 
a result of a spinal disorder: the hypoglossal nerve, the superior laryngeal nerve, and the 
recurrent laryngeal nerve.  Damage to these nerves can affect swallowing safety and efficiency 
at the oral and pharyngeal phases, decreasing airway protection and increasing the risk of 
aspiration.  In addition, injury or progressing disease at cervical and thoracic spinal levels can 
also impact an individual’s respiratory capacity (Mansel & Norman, 1990).  As respiration and 
swallowing are tightly synchronized, dysfunction in one process may greatly impair 
performance in the other.  In this study, we propose to further examine the relationship 
between respiration and swallowing in the spinal disorders population, in order to better 
understand how impairment in one system may influence the other.   
We have two specific aims: 
Aim 1:  To assess swallowing safety and efficiency for different consistencies in spinal 
disorders.  
In this project, we will collect videofluoroscopic measures of swallowing in individuals with 
spinal disorders using barium stimuli across the continuum of liquid consistency. Static 
measures of tongue pressure generation during maximum isometric and saliva swallowing tasks 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
will be collected to provide reference data regarding tongue strength. Significance: This will 
show the impact of consistency on bolus flow through the oropharynx, controlling for the 
tongue forces used in swallowing. Thickened liquids are often used as a compensatory strategy 
for individuals with swallowing safety and efficiency concerns.  Evaluating the flow of different 
liquid consistencies in the spinal disorders population may yield useful information regarding 
future therapeutic use of diet texture modification for individuals with swallowing impairments. 
 
 
Aim 2: To explore the relationship between respiratory capacity and swallowing function in 
spinal disorders.  In this experiment, we will collect reference data regarding respiratory 
capacity and concurrent measures of airflow pattern during swallowing with stimuli of varying 
liquid consistencies (measured under videofluoroscopy).  Significance: This will determine how 
respiratory capacity may influence swallowing function, and specifically which swallowing 
parameters may be affected by reduced respiratory capacity, further explaining the relationship 
between respiration and swallowing in this population.  The impact of fluid consistency will be 
incorporated into this analysis of respiratory-swallow relationships. 
Methods 
Participants 
This project will aim to recruit a sample of adults, aged 18 years or older, diagnosed with a 
spinal disorder with an injury level at the cervical or upper thoracic level (thoracic segment 6 or 
higher).  Participants will be asked to complete all data collection sessions: 1) intake 
appointment, 2) session 2 (videofluoroscopy).   
 
Exclusion Criteria 
Participants with spinal disorders will be accepted and deemed eligible for participation in the 
study provided they do not fulfill any of the following exclusion criteria: 
- 
Prior history of swallowing, motor speech, gastro‐esophageal difficulties, chronic 
sinusitis or taste disturbance. 
- 
Neurological difficulties unrelated to their spinal disorder (e.g. Stroke, Parkinson 
disease, etc).  
- 
Cognitive communication difficulties that may hinder ability to participate. 
- 
Current use of mechanical ventilation  
- 
External instrumentation around the head/neck that would obstruct the field of view 
during the videofluoroscopy exam (e.g. cervical collar). 
- 
Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based 
thickeners, which carry a significant carbohydrate load). 
- 
Known allergies to latex, food coloring or dental glue (due to the probability that these 
items will come into contact with the oral mucosa during data collection). 
- 
Children and pregnant women (due to the use of radiation during the videofluoroscopic 
examination). 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
- 
Occupational radiation exposure such that the addition of a videofluoroscopy is likely to 
yield a total exposure exceeding 10 mSv (i.e., half the allowed Ontario annual limit for 
occupationally exposed workers). 
These exclusion criteria will be confirmed using a self‐report questionnaire form at the time of 
intake into the study.  Any questions will be clarified through discussion with the research 
assistant responsible for participant intake, and, where necessary with the principal 
investigator. 
Recruitment 
We propose to recruit approximately 30 participants with a variety of spinal disorders.  
Participants will be recruited from Toronto Rehabilitation Institute – Lyndhurst Centre using the 
Centralized Recruitment process.  The Patient Research Liaison will pre-screen patients for 
eligibility in the study, and provide them with an information sheet discussing the aims of the 
study.   If the individual is interested in participating in this study, the Patient Research Liaison 
will contact a member of the research team to organize further screening.  Informed consent 
will be conducted by a member of the research team.  The estimated cost of using Centralized 
Recruitment for this project is approximately $ 2307.95.     
Stimuli 
An array of barium stimuli in thin, slightly-thick, mildly-thick, moderately-thick and extremely-
thick consistencies, defined using the International Dysphagia Diet Standardisation Initiative 
(IDDSI) gravity-flow measures, have been developed in the Swallowing Rehabilitation Research 
Laboratory for the purpose of this study. The barium stimuli will be prepared using E-Z-Paque® 
barium in 20% w/v barium concentration(84) with starch and gum-based thickening agents 
(Nestlé Resource® ThickenUp® and ThickenUp Clear®).  
All stimuli will be prepared in the Swallowing Rehabilitation Research Laboratory not longer 
than 3 hours prior to scheduled use, according to a strict standard operating procedure. 
Following preparation, stimuli will be refrigerated until needed.  Barium stimuli will be 
transported to the radiology suite at Toronto General Hospital in a cooler, as per routine clinical 
procedures. 
Data to be Collected from each Participant 
The following types of data will be collected from the participants: 
a) An intake questionnaire noting age, sex, ethnicity, height, weight, and race data and 
confirming eligibility based on the absence of reported exclusion criteria. 
b) During the intake process, we will review a list of conditions that could alter the results 
of the research study and identify whether any of these conditions apply. This will 
include disclosing the use of any medications that the participant is are currently taking, 
in order to allow us to control for the possible influence of medication on oral sensory 
and motor function. Medications do not qualify as the basis for exclusion. However, it is 
important for us to collect information regarding the use of benzodiazepines and 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
neuroleptic medications that are known to have possible effects on swallowing, 
particularly with respect to causing xerostomia (dry mouth). 
c) History of injury/disease (e.g. level of injury, surgical approach used), swallowing 
function, and respiratory capacity 
d) Static measure of tongue pressure using the Iowa Oral Pressure Instrument, consisting 
of 3 repetitions of maximum anterior tongue pressures and 3 saliva swallows 
e) Respiratory measures including full vital capacity and tidal volume 
f) Nasal airflow measurements, collected using a nasal cannula coupled with the 
KayPENTAX Swallowing Signals Lab 
g) Tracheal sounds and accelerometry collected using the Patch. Digitized sound and 
accelerometry data will be transferred from the internal memory card on the Patch to a 
computer for analysis.  
h) A videofluoroscopy recording of swallowing collected at a pulse rate of 30 pulses per 
second and video capture at 30 frames per second. 
 
Data Collection Procedures 
Prior to videofluroscopic data collection during the second session, the participant will be 
seated in a chair for sensor attachment.   
A small patch will be attached to the participant’s neck using double sided adhesive and 
medical tape.  The tracheal sounds and accelerometry signals will be captured on an internal 
memory card on the Patch itself. Digitized sound and accelerometer data will be transferred 
from the internal memory card to a computer for analysis. Tracheal sounds and accelerometry 
have been used to diagnose sleep apnea, which is characterized by apneas and hypopneas. 
Non-invasive breathing recordings have been used in previous studies (REB#09-051, REB#10-
019, REB#10-037REB#12-0042-AE, REB#14-7954D) and the latest version hardware in REB#15-
8967-DE. This device has been proven safe in other research studies conducted here at TRI.   
 
 
 
Figure 1.The Patch placement (reference REB#15-8967-DE).   
 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
Spirometry measures will be collected, including full vital capacity and tidal volume using a 
handheld spirometer.   
 
 
The nasal cannula flexible prongs will then be positioned within the participant’s nares, curving 
downwards, with the tubing of the nasal cannula wrapped around and behind the ears.  The 
tautness of the cannula will be adjusted to fit the participant comfortably.    
 
The nasal cannula will be connected to the KayPENTAX Digital Swallow Workstation Swallowing 
Signals Lab equipment, which is located on a properly insulated cart with an uninterrupted 
power supply and isolation transformer. This equipment and procedure has been used in prior 
experiments in the PI’s lab, with no history of adverse events. 
Participants will be asked to swallow the barium stimuli previously developed in 
videofluoroscopy, with concurrent measurement of nasal airflow. Videofluoroscopy will be 
performed at maximum temporal resolution (30 pulses/second) and captured at 30 
frames/second. Participants will be asked to swallow 3 boluses per stimuli type for a total of 18 
bolus sips: 3 sips of thin barium; 3 sips per barium consistency prepared with a gum-based 
thickener (slightly, mildly, moderately, and extremely thick), and 3 sips of moderately thick 
barium prepared with a starch-based thickener.  The stimuli will be presented in order of 
increasing consistency. Participants will be asked to take naturally sized sips of each stimulus 
from cups containing 40 ml. Cup weights will be measured before and after each sip on a digital 
balance so that sip volume and mass can be calculated. 
Data Processing 
The videofluoroscopy recordings will be spliced into single bolus clips and the audio channel will 
be muted to remove cues that might bias rating. Blinded videofluoroscopy rating will then be 
performed in duplicate by trained raters in the Steele Lab following established procedures.  
Discrepancies between raters will be flagged and resolved at consensus meetings, as 
required.  These procedures will yield a large number of parameters for each swallow, as listed 
below: 
a) Bolus transit time from ramus of mandible to vallecular pit (in ms); 
b) Bolus dwell time in pharynx from ramus of mandible to laryngeal vestibule closure (in 
ms); 
c) Pharyngeal bolus transit time from ramus of mandible to upper esophageal sphincter 
opening (in ms); 
d) Bolus transit time from ramus of mandible to tail exiting the upper esophageal sphincter 
(in ms); 
e) Laryngeal vestibule reaction time, from the onset of laryngeal elevation till full closure 
of the laryngeal vestibule is achieved (in ms); 
f) Amount of residual left behind in the valleculae and pyriform sinuses after the initial 
swallow (measured using the Normalized Residue Ratio Scale; 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
g) Number of swallows for the bolus; 
The airflow measurements collected via the nasal cannula will be rated in duplicate by trained 
raters in the Steele Lab.  Discrepancies in ratings will be flagged and resolved at consensus 
meetings, as needed.  The following airflow measurements will be collected and analyzed.   
a) Respiratory phase pattern pre- and post-swallow; 
b) Respiratory pause duration. 
The following airflow measurements will be collected via the handheld spirometer.  These 
measures will be recorded from the device by a research team member.     
a) Full vital capacity 
b) Tidal volume 
Tracheal sounds and accelerometry will be collected using the Patch, providing data regarding 
flow rate and intensity. 
 
Data Analysis 
We will determine the extent to which parameters measured during ASPEKT rating (Analysis of 
Swallowing Physiology: Events, Kinematics, & Timing) differ between participants with spinal 
disorders and reference data from the Steele lab for healthy individuals (REB#15-9431-D).  Data 
analyses will focus on evaluating whether the physiological parameters identified using ASPEKT, 
primarily laryngeal vestibule reaction time, explain differences in primary swallowing outcomes 
(Penetration-Aspiration score and pharyngeal residue) between groups.  The primary 
respiratory outcome measures (respiratory phase pattern and pause duration) will be 
compared between participants with spinal disorders and data referenced from related studies 
evaluating these patterns in healthy adults (REB#15-9431-D).  Using path analysis, the 
relationship between swallowing physiology and respiratory capacity may be illustrated, and 
the resulting effect on swallowing safety and efficiency in this population.   
In addition, the relationship between stimulus consistency and the two primary outcomes 
(Penetration-Aspiration score and pharyngeal residue) will be analyzed to further our 
understanding of the impact of different liquid flow levels on swallowing function and 
physiology in the spinal disorders population.   
Risks and Benefits 
Risks 
The following risks will be disclosed to all participants prior to obtaining their consent to 
participate: 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
a) It is possible that participants may dislike the taste or texture of some of the thickened 
liquid stimuli in the study. Participants will be reminded that they are free to discontinue 
participation at any time. 
b) It is possible that participants may experience some fatigue during the data collection 
session. Participants will be reminded that they should disclose any fatigue or discomfort to 
the research team, and that they are free to discontinue any particular session or to 
withdraw from the study at any time. 
c) Participants will receive exposure to radiation during the videofluoroscopy.  Based on a 
previous videofluoroscopic study that we have conducted in healthy adults (Molfenter and 
Steele, 2013), this study is expected to involve 118+/-18 seconds of radiation exposure, with 
an associated dose estimate of <0.35 milliSieverts. Moro and Cazzani (2006) showed that 
this dose (0.35mSv) corresponds to a risk of 1 in 39,000 of developing a radiation-induced 
stochastic effect from a videofluoroscopy. We will use a warning bell to alert the data 
collection team to exposure time, and will terminate the protocol at the first opportunity 
following the bell. 
d) Aspiration (entry of material into the airway) is a possible risk during the videofluoroscopic 
swallowing study that will be performed. This risk is always present for videofluorscopic 
swallowing studies, which are intended to document the presence and severity of 
swallowing abnormalities, including (but not limited to) aspiration. When aspiration is 
observed, standard procedures will be followed to encourage coughing and throat clearing 
to expel the aspirated material.  After the 4th bolus involving an observation of aspiration, 
the protocol will be terminated immediately. Any participant who experiences aspiration 
will be counseled regarding aspiration prevention strategies and aspiration‐risk following 
the videofluoroscopy. 
e) Choking is an extremely unlikely event.  However, in the event of choking, routine 
emergency procedures will be followed.  All study personnel carry current CPR certification.  
f) In the unlikely event that an incidental finding is noted on the videofluoroscopy (such as a 
diverticulum or a mass) the attending SRRL licensed speech-language pathologist will 
consult the on-call radiologist and generate a clinical report documenting the observation. 
These findings will be communicated with the participant as per usual clinical practice. 
 
Benefits 
There are no benefits anticipated for participants in this study. 
Privacy and Confidentiality 
Routine practices for ensuring the confidentiality and privacy of all participants will be followed 
in this study. All research personnel at the Toronto Rehabilitation Institute are required to sign 
a confidentiality agreement at the time of hire. Participants will be assigned a non‐identifying 
alphanumeric study code, and the master key for this code will be retained separately by the 
Principal Investigator in a password‐protected file on a secure, password‐protected, encrypted 
research server. Daily back‐up of this research server is performed centrally at the Toronto 
Rehabilitation Institute to protect against data loss. Hard copies of the participant consent 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
forms will be maintained in a binder, kept in a locked filing cabinet in the Swallowing 
Rehabilitation Research Lab.  
 
All waveform and videofluoroscopic data will be stored electronically on the secure, password 
protected, encrypted research server. Any hard copy data will be transcribed into an electronic 
file (stored on the server), and the hard copy records will be stored in a locked filing cabinet in 
the Swallowing Rehabilitation Research Lab. Only the participant’s alphanumeric study code 
number will appear on the data collection sheets and in the data collection files. 
 
Access to participant information and experimental raw data will be restricted to the study 
personnel named in this application. All records will be destroyed after 10 years under the 
supervision of Dr. Steele. 
 
Compensation 
Data collection for each participant will involve 2 separate appointments: a) intake session; b) 
Session 2 (videofluoroscopy and respiratory measures). Each appointment is expected to last 
approximately 1 hour. The intake session will be completed at Toronto Rehabilitation Institute – 
Lyndhurst, whereas the second session will be conducted in the videofluoroscopy suite at the 
Toronto General Hospital.  Transportation to and from the Toronto General Hospital, for the 
second session, will be provided for participants and accompanying attendants.  An honorarium 
of $100 will be provided to each participant who participates in the study.  This will be paid at 
the end of the final study visit. 
Transportation 
Transportation to and from the Toronto General Hospital, for the second session, will be provided for 
participants and accompanying attendants.  Participants and accompanying registered nurse will be 
picked up from Toronto Rehabilitation Institute-Lyndhurst, will be dropped off at Toronto General 
Hospital, and then will be returned to Toronto Rehabilitation Institute-Lyndhurst following completion 
of the second session.  This service, including pick-up times, will be arranged by the research team, and 
communicated to the participant and nursing manager.   
Conflicts of Interest 
Professor Steele, the principal investigator, is a member of the board of directors for the 
International Dysphagia Diet Standardisation Initiative (www.iddsi.org), a not-for-profit 
corporation, which developed the framework for the labelling, classification and testing of 
liquid thickness that will be used in this study.  Professor Steele also holds current and prior 
research contracts with Bracco Canada and Nestlé Health Science, who are manufacturers of 
the barium products and thickening agents that will be used in this study.  She has also served 
in an advisory capacity on expert panels for Nestlé Health Science. These relationships will be 
disclosed to participants in the study information sheet. All products for use in the study will be 
purchased.  Neither Bracco Canada nor Nestlé Health Science will have any role as sponsors of 
this study.  Dr. Steele will not receive any financial payment, either personally or to the lab, 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
related to the use of Nestlé or Bracco products in this study. Teresa Valenzano receives a 
stipend from the University of Toronto and a scholarship from the Toronto Rehabilitation 
Institute. 
Informed Consent Process 
All participants who show an interest in participating will be provided with detailed information 
about this study via the Participant Information Sheet and Consent Form at least one week 
prior to the scheduled intake appointment. Only after confirming they have understood all the 
information that is provided and after verifying they have no more questions, can they sign the 
consent form. A copy of the consent form will be provided to them. When the ability to 
comprehend the study is in question, we will also request assent from the patient’s substitute 
decision maker prior to enrolling a patient in the study. 
The consent form includes a specific section requesting consent to use of study-related images 
for future educational and teaching purposes. 
Scholarly Review 
The larger project of which this is a subproject has undergone scientific review by the MFSR 
Study Section of the National Institutes of Health (USA). 
Additional Ethics Reviews 
There are no additional ethics reviews planned for this project.   
Contracts 
There are no contracts required for this project.  This project will be conducted exclusively at 
the Toronto Rehabilitation Institute. 
Budgets 
All costs for this study will be covered by the grant received from the National Institutes of 
Health.   
 
 

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Steele. Respiratory Capacity and Swallowing Function in Spinal Disorders.  
REB#: 16-6310.0 
Version date: March 23rd, 2017 
 
 
References 
Boos, N., & Aebi, M. (2008). Spinal disorders: Fundamentals of diagnosis and treatment. Berlin: 
Springer.  
Mansel, J. K., & Norman, J. R. (1990). Respiratory Complications and Management of Spinal 
Cord Injuries. Chest, 97(6), 1446-1452. doi:10.1378/chest.97.6.1446  
Molfenter, S.M. and C.M. Steele, Variation in temporal measures of swallowing: sex and volume 
effects. Dysphagia, 2013. 28(2): p. 226-33. 
Moro, L., & Cazzani, C. (2006). Dynamic swallowing study and radiation dose to patients. La 
Radiologia Medica, 111(1), 123-129. doi:10.1007/s11547-006-0013-8