Aspiration in Acute Respiratory Failure Survivors
Phase: NA
Conditions: Dysphagia
Sponsor: University of Colorado, Denver

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PROTOCOL #: 12-0184
COMIRB Protocol 
Protocol Version 3, 07/09/2015
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490   TELEPHONE: 303-724-1055 Fax: 303-724-0990
  
Project Title: Aspiration in Acute Respiratory Failure Survivors
Principle Investigator:   Marc Moss MD
I. Hypothesis and Specific Aims
We hypothesize that the BSE assessment of swallowing certain consistencies will provide the most 
accurate diagnosis of aspiration.
A.  Specific Aim #1: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will 
accurately and efficiently diagnose aspiration in ARF survivors.
B.  Specific Aim #2: To identify abnormalities in laryngeal structure and swallowing physiology that are 
associated with aspiration in ARF survivors.
.
Study Design: Prospective cohort study of patients with acute respiratory failure who require mechanical 
ventilation for more than 48 hours. 
Inclusion Criteria:
1. Admission to an ICU.
2. Mechanical ventilation with an endotracheal tube for greater than 48 hours. 
Exclusion Criteria:
1. Age < 18 years 
2. Contraindication to enteral nutrition administration.
3. Pre-existing or acute primary central or peripheral neuromuscular disorder 
4. Pre-existing history of dysphagia or aspiration.
5. Pre-existing head and neck cancer or surgery.
6. Presence of a tracheostomy.
7. Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
8. Unable to participate due to altered mental status
9. Extubated for greater than 72 hours. 
10. Inability to obtain informed consent from patient or an appropriate surrogate.
11. Pregnancy
12.  Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the 
follow up period
First, a SLP will perform a comprehensive BSE on each ARF survivor. 
Subsequently a second blinded SLP/investigator will perform the FEES to determine whether aspiration is 
truly present. The FEES examination will also identify abnormalities associated with aspiration.
For Aim #1: Primary Outcome Variable: Aspiration (PAS score of ≥6) on the FEES with any of the five 
feedings. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration.
Statistical analysis: Recursive partitioning or Classification and Regress Tree (CART) analysis creates a 
tree that asks a series of yes/no questions, taking the user down different branches depending on the 
answers. At the end of each branch will be an estimated probability of outcome.  
For Aim #2: Primary outcome variables: Presence of abnormalities in the four laryngeal functions and two 
swallowing physiology measures. 
Statistical analysis: For each outcome and independent variable, a univariate logistic regression model will 
be developed.  
Overall Sample Size Determination: In a simulated data analysis, a sample size of 200 yielded an area 
under the curve (AUC) of .75 for the resultant tree algorithm. To be conservative, we will enroll a total of 225 
patients.
Significance:  For the 455,000 acute respiratory failure (ARF) survivors each year, aspiration is a 
devastating complication that can develop after the initiation of oral nutrition.1;2 Occurring in as many 
as 44% of ARF survivors, aspiration is associated with many deleterious consequences including 
pneumonia, percutaneous feeding tube placement, long term care facility admission, and increased hospital 
COMIRB
APPROVED
05-Aug-2015

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Figure 1: R21 Proposal Overview:
 The outer circle represents our 
multidisciplinary infrastructure.
mortality.3-6 The complications of aspiration must be weighed against the consequences of inappropriately 
delaying the resumption of oral feeding. Delayed resumption of oral nutrition is associated with prolonged 
enteral tube feeding, increased caregiver burden, patient dissatisfaction, and increased health-related 
costs.7-10 Improving the ability to easily and accurately diagnose aspiration in ARF survivors would both 
reduce the frequency and severity of aspiration and limit the problems associated with delaying oral 
nutrition. This proposal will develop an effective non-invasive bedside diagnostic clinical prediction rule 
(CPR) to detect aspiration in ARF survivors.
Speech language pathologists (SLPs) determine when ARF survivors can resume oral feeding.11 
Based on our national survey, SLPs commonly rely upon the bedside swallow evaluation (BSE) to provide 
feeding recommendations for ARF survivors.11 The BSE consists of a comprehensive history and physical 
examination followed by assessment of the patient’s ability to swallow foods and liquids of different 
consistencies. SLPs do not routinely order or perform gold standard tests such as a videofluoroscopic 
swallow study (VFSS) or flexible endoscopic swallow study (FEES).11 This is in part due to appropriate 
safety concerns about transporting critically ill patients to radiology for a VFSS and the lack of equipment or 
expertise to perform the FEES.11  In patients with stroke or head and neck cancer, diagnostic CPRs have 
been developed that detect aspiration based on specific components of the BSE. 12-22 Due to differences in 
the reasons for aspiration, CPRs for these patients are unlikely to be effective for ARF survivors. 12-14;16;20 As 
a result, there are no BSE-based diagnostic non-invasive CPRs 
that SLPs can use to provide feeding recommendations for ARF 
survivors.  
Using recursive partitioning analysis (RPA), we will develop 
an effective diagnostic CPR to accurately detect 
aspiration in ARF survivors. RPA has been previously 
used to create clinically useful CPRs including: 
identifying patients with chest pain that require 
hospitalization and selecting trauma patients that benefit 
from a cervical CT scan.23;24 Based on our preliminary 
data, we hypothesize that the BSE assessment of 
swallowing certain consistencies will provide the most 
accurate diagnosis of aspiration.  We propose to 
conduct a multi-center study that will enroll ARF 
survivors within 72 hours after extubation. First, a SLP 
will perform a comprehensive BSE on each ARF 
survivor. Subsequently a second blinded 
SLP/investigator will perform the FEES to determine 
whether aspiration is truly present (Figure 1). 
In ARF survivors, the mechanisms responsible for 
aspiration are also relatively unexplored.25;26 Though 
many mechanisms may contribute to aspiration in ARF 
survivors, abnormalities in laryngeal structure and swallowing physiology likely play a prominent role in the 
development of aspiration.25 Specific abnormalities that may be responsible for aspiration include: laryngeal 
sensory defects and edema, vocal fold immobility and granuloma formation, delayed swallowing time, and 
reduced pharyngeal clearance.25;27-31  Building on our compelling data, the FEES examination will identify 
abnormalities associated with aspiration, and pave the way for the development for targeted therapies to 
prevent and treat aspiration.
Aim #1: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and 
efficiently diagnose aspiration in ARF survivors.
Aim #2: To identify abnormalities in laryngeal structure and swallowing physiology that are associated with 
aspiration in ARF survivors.
Dr. Moss’ interest in dysphagia began with his 2000 New England Journal of Medicine article identifying the 
harmful effects of using blue dye to detect aspiration in ARF patients.32 Our multidisciplinary team 
established a strong collaboration with Dr. Susan Langmore and her exemplary research group at Boston 
University.26;33-49 Dr. Langmore developed the FEES procedure and she is one of the pioneers of dysphagia-
related research.50;51 These two productive research teams have contributed to the recent increased 
awareness of swallowing dysfunction and aspiration in ARF survivors.25;26;33;52 Collectively, we have 

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generated substantial preliminary data demonstrating both the need for better diagnostic CPRs and for 
studies that identify the mechanisms responsible for aspiration. Utilizing our established research 
infrastructures, we are ideally positioned to conduct and complete the proposed multidisciplinary research 
studies. 
TRIAL DESCRIPTION
Background: 
Dysphagia and subsequent aspiration are common in survivors of acute respiratory failure (ARF).  
Each year more than 700,000 patients develop ARF requiring mechanical ventilation. The care of these 
patients costs an estimated $27 billion, or 12% of all hospital expenses.2 Based on a 65% rate of survival, 
455,000 ARF patients are extubated and leave the hospital.2 Unfortunately, many ARF survivors must cope 
with a variety of consequences of their critical illness.53-58 One previously under-recognized consequence of 
ARF is dysphagia and subsequent aspiration.6;25;26 As summarized in our two recently published clinical 
reviews on dysphagia and aspiration during recovery from critical illness, as many as 44% of ARF survivors 
(200,000 patients annually) have difficulty with aspiration.25;26 Whether clinically significant or “silent” 
(without symptoms), aspiration is associated with pneumonia, percutaneous feeding tube placement, an 
increased need for institutionalized care, and increased hospital mortality. 9;59-61
The bedside swallowing evaluation (BSE) is commonly used to diagnose aspiration in ARF 
survivors. Every 90 seconds, a critical care practitioner in the United States determines when it is safe to 
restart oral nutrition for an ARF survivor.1;2  Most critical care practitioners delegate this decision to speech-
language pathologists (SLPs).11 In more than 60% of ARF survivors, SLPs perform a bedside evaluation 
(BSE) as their sole assessment to detect aspiration and determine feeding recommendations.11 The BSE 
consists of two components: 1) a history and physical examination, and 2) an assessment of the patient’s 
ability to swallow foods and liquids of different consistencies. SLPs do not routinely order or perform gold 
standard tests such as a videofluoroscopic swallow study (VFSS) or flexible endoscopic swallow study 
(FEES) to detect aspiration.11
The BSE may not accurately diagnose aspiration in ARF survivors. By combining specific components 
of the BSE, clinical prediction rules (CPRs) have been developed for patients with head and neck cancer or 
cerebrovascular accidents.16-18;31;62-70 These disease-specific CPRs may not accurately detect aspiration in 
ARF survivors for the following reasons. 1) The proposed mechanisms responsible for aspiration in ARF 
survivors increase the likelihood of silent aspiration that would not be routinely detected on a BSE.9;59-61 2) 
Decreased saliva production after radiation alters swallowing function and has been included in head and 
cancer specific CPRs.12-14;20;66;71 This criterion would most likely not contribute to aspiration in ARF 
survivors. 3) Some aspiration CPRs were developed using only patients referred for formal swallowing 
evaluations; creating both a selection bias and limiting generalizability of the results.69;70;72 4) Due to their 
diminished respiratory reserve, the consequences of aspiration are greater in ARF survivors.73 Therefore 
CPRs might need to be more sensitive for the detection of aspiration. 5) Certain CPRs were developed 
without comparison to a gold standard test of aspiration such as a VFSS or FEES.69;70;72 6) The 3 ounce 
water swallow test (3-WST) is a sensitive initial screening test in hospitalized patients. However, it is unclear 
whether the 3-WST applies to ARF survivors, or what BSE components could be combined with the 3-WST 
to confirm aspiration.74-76 
Because the mechanisms responsible for aspiration are essentially unknown, there are no medical 
therapies to treat or prevent aspiration in ARF survivors.26 Currently SLPs treat patients with 
suspected aspiration by restricting oral nutrition, adjusting the consistency of their food or liquids, or 
teaching patients different swallowing maneuvers.77-90 All of these interventions limit the chance of 
aspiration but do not treat the underlying cause of the swallowing dysfunction.77-90 There are several 
abnormalities in ARF survivors that may be responsible for dysphagia and subsequent aspiration (Figure 
2). These abnormalities may be caused by the prior 
endotracheal tube, deconditioning, critical illness 
polyneuromyopathy, reduced pharyngeal clearance, 
and/or limited respiratory reserve.27-31;52;91-96 We 
identified specific abnormalities in laryngeal function 
and swallowing physiology that are associated with 
aspiration in ARF survivors (see preliminary data).52 
Additional studies are needed to delineate the 

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mechanisms responsible for aspiration in these patients.
PRELIMINARY DATA: 1.Longer duration of mechanical ventilation is associated with dysphagia.5 We 
conducted a cohort study of 446 ARF patients admitted to the Medical ICU who required mechanical 
ventilation and received a BSE.  Patients with prior neuromuscular disorders were excluded.  Dysphagia 
was present in 84% of patients (mild in 52% and moderate/severe in 48%). After adjustment, longer duration 
of mechanical ventilation was independently associated with moderate/severe dysphagia (AOR 2.84 [1.78-
4.56], p <0.01). These results suggest that dysphagia is common in ARF survivors.
2. In ARF survivors, dysphagia can persist until hospital discharge and is associated with prolonged 
hospitalization and delayed oral nutrition. 5 Moderate/severe dysphagia was independently associated 
with the composite outcome of pneumonia, re-intubation, or in-hospital death (AOR 3.31 [1.78-4.56], 
p<0.01) (Figure 3). In ARF survivors, dysphagia was still present in 55% of patients at hospital discharge. 
Hospital duration was longer in ARF survivors with dysphagia compared to those without dysphagia (8 [5-
15] days vs 5 [3-8] days after the initial BSE was performed, p<0.01). Patients with moderate/severe 
dysphagia were more likely to be kept NPO after the initial BSE (74% vs 15%, p<0.01) and receive a 
surgical feeding tube during hospitalization 
(15% vs 5%, p<0.01).  
3. Our nationwide survey of SLPs 
identified current practices to detect 
aspiration in ARF survivors. 11  We 
designed, validated, and distributed a survey 
to 1,966 SLPs working in an inpatient setting. 
Each survey included questions concerning 
SLP staffing and availability, and methods 
used in the diagnosis and treatment of 
dysphagia and aspiration.  A total of 836 
SLPs completed their survey (43%), 801 of 
whom were actively practicing.  This survey 
represents the largest published study to 
date of SLP practices for ARF survivors. 
4. There is currently no uniformly used diagnostic CPR to detect aspiration in ARF survivors.11  Only 
29% of hospitals have formal guidelines for when critical care providers should consult SLPs in the 
evaluation of ARF survivors. Most SLPs performed the BSE on average 24 hours after extubation. 
Importantly, the majority of SLPs (60%) 
only use the BSE to identify aspiration in 
ARF survivors. Gold standard tests (VFSS 
and FES) are not commonly used, and 
there is significant geographic variability in 
their use (Figure 4). VFSS and FEES are 
also more available and more utilized at 
university hospitals when compared to 
community hospitals (p < 0.01).
5. We already have enrolled 26 ARF 
survivors in Aim #1 without any 
adverse events. A total of 50% of ARF 
survivors had evidence of aspiration on 
FEES evaluation. The diagnostic accuracy 
of each individual assessment of 
Figure 3

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swallowing foods and liquids of different consistencies appears to be poor for detecting true aspiration (see 
Table 1).  These data demonstrate feasibility to complete the studies in Aim #1. By combining specific 
components of the BSE, we anticipate that we will be able to develop a more accurate diagnostic CPR for 
aspiration. 
6. In ARF survivors, abnormalities of laryngeal function and swallowing physiology are associated 
with aspiration (Aim #2 data). At Boston University Medical Center, 59 ARF survivors who required 
mechanical ventilation for at least 48 hours underwent 
FEES examination including laryngeal structure and 
swallowing physiology assessment. Upper airway 
abnormalities were common including: laryngeal edema, 
vocal cord immobility, and vocal cord granuloma 
formation. Vocal cord granulomas were associated with 
severe dysphagia or aspiration (p = 0.04). This work has 
been submitted for publication and demonstrates the 
feasibility to complete the studies in Aim #2.
OBJECTIVES
To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently 
diagnose aspiration in ARF survivors.
To identify abnormalities in laryngeal structure and swallowing physiology that are associated with aspiration 
in ARF survivors.
Primary Hypothesis: We hypothesize that the BSE assessment of swallowing certain consistencies will 
provide the most accurate diagnosis of aspiration.
1.  Screening and recruitment:  
Patients meeting enrollment criteria will be approached for informed consent no later than 72 hours after 
extubation. Surrogate consent may be used if patients are unable to provide their own informed consent due 
to lack of decisional capacity.
Inclusion Criteria: Subjects will be eligible to participate in the study if they meet all of the following 
criteria:
1. Admission to a University of Colorado Hospital ICU
2. Mechanical ventilation support through an endotracheal tube for greater than 48 hours
Exclusion Criteria: 
1. Age < 18 years 
2. Contraindication to enteral nutrition administration.
3. Pre-existing or acute primary central or peripheral neuromuscular disorder 
4. Pre-existing history of dysphagia or aspiration.
5. Pre-existing head and neck cancer or surgery.
6. Presence of a tracheostomy.
7. Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
8. Unable to participate due to altered mental status
9. Extubated for greater than 72 hours. 
10. Inability to obtain informed consent from patient or an appropriate surrogate.
11. Pregnancy
12.  Imprisoned at the time of admission, anytime during the hospitalization, or anytime during the 
follow up period
If patients meet an exclusion criterion, they can be re-evaluated to determine if the exclusion criteria no 
longer exists; up to 72 hours after extubation. The presence of delirium is the one exclusion criterion that is 

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most likely to change over time and require repeated assessments.
There is no minimal amount of time that is required after extubation to be enrolled into the study (as long as 
the patient meets the inclusion criteria and does not currently meet any of the exclusion criteria. 
After enrollment, the research coordinator should complete the demographic information on the Case 
Report Forms. No fields on the Case Report Forms should be left blank. The research coordinator should 
also contact and the SLP who will perform the BSE, and the second SLP who will perform the FEES. The 
research coordinator should arrange a specific time that the BSE and FEES will be performed. 
Screening and recruitment techniques:
Every new ICU admission receiving mechanical ventilation will be screened, wherein an established 
treatment relationship exists. This will include but not be limited to admissions from the ED, wards, and 
operating room. We will also assess patients transferred from outside hospitals. The enrollment window for 
these patients will include the time during admission at the outside hospital and during transfer. 
The research coordinators or site PI will meet with the new incoming groups of ICU residents as part of their 
unit orientation. During this time, the residents will be alerted to each of the study inclusion and exclusion 
criteria.  We would also recommend developing printed laminated cards with important study related and 
contact for the housestaff and other key members of the ICU teams. Each day, the research coordinator will 
identify each patient who is endotracheally intubated and receiving mechanical ventilation for at least 48 
hours. Patients will then be followed until they are extubated.
At the time of extubation, the patient by definition meets inclusion criteria for the study. At this point the 
patient should be entered into the screening log in one of several ways
1. If they meet a permanent exclusion criteria, they should be entered as be excluded from the study
2. If they meet a potentially transient exclusion (like altered mental status), they should be followed for up to 
72 hours after exclusion to determine if the exclusion criteria resolves. If it resolves they should approached 
for enrollment
3. If the patient meets no exclusion criteria, they should be approached about study participation.
4. If they agree to participate and sign the consent form then they are enrolled into the study.
5. If they decline to participate, then they should be entered as an excluded patient.
Informed consent:
Obtaining informed consent is a process that is reviewed by the appropriate members of our research team 
on a monthly basis. All of the personnel involved in screening and patient identification have successfully 
completed the on-line course on the Responsible Conduct of Research. Informed consent will be obtained 
from each patient or legally authorized representative (LAR) prior to enrollment in the trial. No study 
procedures will be done prior to obtaining informed consent. Permission to approach patients and/or LARs 
will be requested from the attending physicians.
In general our methods for obtaining informed consent include the following: 1. identification and contact of 
appropriate parties to perform informed consent, 2. arrangement of a mutually acceptable meeting time with 
this party in a private conference room or in the patient’s room, and 3. a lengthy discussion between the 
study investigator and the interested party.  The discussion includes an update of the patient’s overall 
condition justifying the rationale for inclusion of the patient into the specific trial.  The consent form is 
reviewed in detail including the background information and rationale regarding the specific intervention of 
the study, potential risks and options.  Patients or their representatives are informed of their rights as a 
research subject and are informed of their ability to discontinue study participation at any time throughout 
the trial.  Subjects or their representatives are given the opportunity to ask any questions regarding the 
verbally described consent form.  Following this discussion, opportunity is given to privately read the 
consent form.  If the patient or representative is illiterate, the consent form is read to them.  After sufficient 
time, an additional question and answer session is performed if needed. 

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A few key points to the informed consent process.
1. Sit down when you are taking to the patient and/or surrogate.
2. Explain who you are and that you normally work with patients in the intensive care unit.
3. Explain that you are here to help determine if the patient is swallowing normally. 
4. Explain that difficulty swallowing is common after being on a breathing machine
5. State that the standard tests to determine whether someone can swallow properly after being on a 
breathing machine are to have a nurse or speech therapist to observe a person swallow liquids and foods of 
different consistencies. However, these tests are not perfect. Sometimes it appears that the patient can eat 
normally, and they are actually swallowing things down the wrong tube (into their lungs), Other times, it 
appears that the patient is not swallowing properly when they actually are swallowing properly.
6. In addition to this normal swallowing exam, there is an additional simple test we can do that is above and 
beyond the normal swallowing exam. This additional technique will definitively identify if someone is 
swallowing normally, and allow us to identify the correct strategy for eating. Sometimes we do this test as 
part of the normal patient swallowing evaluation. 
7. The test is simple and down right here in the patient’s room. It takes 5-10 minutes and the patient can 
watch the test if they want. We will put a very small tube (like a very thin straw) down the back of the throat 
so we can see your vocal cords. We will then have you swallow liquids and foods of different consistencies 
and see if the material is actually going down the wrong tube. 
8. Share these results with your doctors so they have the additional information and can use the information 
to potentially take better care of you in regard to your feeding and swallowing. 
If the patient agrees to the study, then the coordinator should contact the SLP who will perform the BSE, 
and the second SLP who will perform the FEES. 
STUDY PROCEDURES:
1. Baseline assessments: 
This information will be collected by the study coordinator at the time of enrollment. 
Patient Age
Patient Gender
Patient Race
Patient Height
Patient Weight
Primary Service
Hospital Admission Date
ICU Admission Date
Intubation Date and Time
Size of the Endotracheal Tube
Extubation Date and Time 
Previous reintubation (y/n)
APACHE II score
Charlson Comorbidity Index
Next, a SLP will perform a comprehensive BSE on each ARF survivor, and a second blinded SLP will 
perform the FEES to determine whether aspiration is truly present. The order of the BSE and FEES exams 
will be randomized. The reason for the random order of the tests is that after several swallows, a patient 
who has not eaten orally in several days or weeks will start to do better as the system “wakes up”.  If the 
BSE always precedes the FEES, it might lead to a false result – it would show more aspiration on the BSE 
than the FEES.  But it won’t be because the BSE was showing a false positive; in fact it is just that the 
patient started to improve by the time he got the second exam.
2. Bedside Evaluation:
The BSE protocol should be performed within 24 hours from the time that the informed consent was signed. 
The BSE protocol will be performed in the same order and the amount of each bolus delivered in the exact 
manner for all patients. Unless there a medical restrictions (due to femoral lines, sacral wounds, etc), all 
BSEs should be performed in a sitting position. The SLP will document the patient position that the BSE was 

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performed.
Part 1: Initial Assessment: The SLP will review the subject’s medical record and become knowledgeable 
with the patient’s medical history. The patient should be seated with the head of the bed as elevated as 
possible.  A physical exam of the aerodigestive system will be performed including respiratory rate; saliva 
formation; lip seal; tongue movement, strength, and coordination; palate movement, gag reflex; cough 
reflex; and voice quality/dysphonia. In addition, the SLP will also determine cough strength in L/min using a 
peak flow meter (HealthScan, Cedar Grove, NJ).
Part 2: Standardized consistency testing: The SLP will then administer five standard consistencies.106 
Some consistencies will be tested twice with different amounts. In general, the bolus should be administered 
with a medicine cup. A straw should only be used for the 3 ounce water test and the 2 ounce patient 
controlled trials.
Boluses will be administered from lowest to highest aspiration risk: 1) ½ tsp, then  1 tsp ice chips , 2) 1 tsp 
of nectar thick liquids,  then 3 tsp of nectar thick liquids, 3) a 2 ounce patient controlled administration of 
nectar thick liquids, 4) 1 tsp of pureed solids (applesauce), then 10 mls of pureed solids (applesauce), 5) 5 
mls of thin liquids (water or milk),15 mls of  thin liquids (water or milk), and a 2 ounce patient controlled 
administration of thin liquids and 6) ¼ of a graham cracker.107 The patient will be instructed to chew the 
graham cracker before swallowing. In order to limit the complexity and duration of our consistency testing, 
honey-thick liquids will be excluded from the protocol. 
The SLP will wait for 10 seconds following the completion of each individual trial before recording the results 
for that consistency. The following adverse outcomes (coughing/choking, change in breath sounds, and 
change in voice quality, throat clearing, or change in pulse oximetry recording by > 10%) will be recorded 
after each trial. 
If the clinician feels it is unsafe to continue with the next bolus consistency, the protocol can be stopped at 
any time.
Coughing/coughing:  Dichotomized as a single cough or choking sound within 10 seconds after diet 
administration (yes/no).
Change in breath sounds:  Breath sounds will be assessed before and 10 seconds after the examination by 
either auscultating over the larynx at the thyro-cricoid space during quiet breathing or listening to the 
patient’s breathing without a stethoscope.  The SLP will record whether they used a stethoscope or not to 
listen for change in breath sounds. Patients will be classified as “gurgling” or “non-gurgling.”  Gurgling is a 
low/medium-pitched rattling sound on inhalation or exhalation.108  
Change in vocal quality:  Baseline vocal quality will be assessed initially and dichotomized as 
normal/abnormal.  Any transition from normal to abnormal vocal quality during feeding will be recorded.
Part 3: Three Ounce Water Swallow Test (3-WST): During the standardized 3-WST, patients receive three 
ounces of water and are instructed to drink the entire amount, via cup or straw, completely and without 
interruption (the cup can be held to the patient’s mouth by the SLP).74;76;109 The 3-WST will be scored as 
pass/fail.  Criteria for failure of the 3-WST are: the inability to drink the entire amount, coughing or choking 
up to 1 minute after completion, or the presence of a wet-hoarse vocal quality. 
At this point the SLP will document their diet recommendations, and whether further invasive testing (MBSS 
or FEES) is indicated. 
Subsequently, the SLP can perform additional testing including specific maneuvers. The results of these 
additional tests will be recorded in the CRF. The SLP will then document their diet recommendations that 
include the knowledge gained from the additional testing. Again the SLP will document whether further 
invasive testing (MBSS or FEES) is indicated. 
Based on these recommendations, the patient will be allowed to advance their diet prior to the performance 
of the FEES, if indicated.
The coordinator should make sure that the BSE CRF is completely filled out before the SLP who completed 
the test leaves the ICU. 

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The BSE form for consistency testing in attached as Appendix.
3. FEES examination: The SLP will review the subject’s medical record and become knowledgeable with 
the patient’s medical history. The FEES examination will be performed by a second SLP who is blinded to 
the results of the BSE. The FEES should be performed within approximately 4 hours of the BSE.
Similar to the BSE, the patient should be seated with the head of the bed as elevated as possible. At the 
discretion of the SLP/investigator, Afrin and Lidocaine spray can be administered into the nasal passage 
before the laryngoscope is inserted. The use of these medications will be noted in the case report form. 
Part 1: First the SLP will perform and videotape the examination of the upper airway.
Velar closure, base of the tongue retraction, laryngeal elevation, right and left vocal cord/arytenoid mobility, 
right and left pharyngeal wall medialization, epiglottic retroflexion, granuloma formation, and upper airway 
edema will be assessed. 
Laryngeal sensation will be assessed by observing the laryngeal adductor reflex (LAR) or a patient 
response to a light touch/poke to the aeryepiglottic folds bilaterally with the tip of the laryngoscope, and 
scored dichotomously.
Part 2: Standardized consistency testing: The SLP will then administer five standard consistencies in two 
trials of each consistency with different amounts.106 
Boluses will be administered from lowest to highest 
aspiration risk: 1) ½ tsp, then  1 tsp ice chips , 2) 1 tsp of 
nectar thick liquids,  then 3 tsp of nectar thick liquids, 3) a 2 
ounce patient controlled administration of nectar thick 
liquids, 4) 1 tsp of pureed solids (applesauce), then 10 mls 
of pureed solids (applesauce), 5) 5 mls of thin liquids (water 
or milk),15 mls of  thin liquids (water or milk), and a 2 ounce 
patient controlled administration of thin liquids and 6) ¼ of a 
graham cracker.107 The patient will be instructed to chew 
the graham cracker before swallowing. In order to limit the 
complexity and duration of our consistency testing, honey-
thick liquids will be excluded from the protocol. 
After the swallow, the laryngoscope will be advanced to closely view the patient’s airway. The SLP will wait 
for 10 seconds following the completion of each individual trial before recording the results for that 
consistency. If necessary, patients will be allowed to drink water between consistency tests to clear any 
remaining residue from their upper airway
 
The entire FEES will be video recorded. The SLP will score each of the trials using the PAS score (Table 3).  
In addition for each of the trials of the consistencies, the SLP will record the following two physiological 
measures: 
1) Swallowing onset time: The time from first bolus visualization until swallow onset.  
2) Incomplete bolus clearance: leaving residue in the pharynx or laryngeal vestibule after a swallow.
Using the video recordings, the quantification of the swallowing onset time and incomplete bolus clearance 
will be determined by a single observer.
Part 3: Three Ounce Water Swallow Test (3-WST): During the standardized 3-WST, patients receive 
three ounces of water and are instructed to drink the entire amount, via cup or straw, completely and without 
interruption (the cup can be held to the patient’s mouth by the SLP).74;76;109 The 3-WST will be scored 
based on the PAS scoring system. 
The results of the different components of the FEES assessment will be made available to the treating team 
if requested. 
The coordinator should make sure that the FEES CRF is completely filled out before the SLP who 
completed the test leaves the ICU. See Appendix for FEES evaluation form.

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4. Outcome Assessments
All patients will be followed for the subsequent outcome assessments.
Date of ICU discharge
ICU length of stay
Date of hospital discharge
Hospital length of stay
Discharge location
Reintubation since enrollment
If yes, date of reintubation
Died during ICU stay
Died during hospital stay
Surgical feeding tube placed?
 
5. Statistical analysis for Aim #1: Recursive partitioning or Classification and Regress Tree (CART) 
analysis creates a tree that asks a series of yes/no questions, taking the user down different branches 
depending on the answers. At the end of each branch will be an estimated probability of outcome. 
Statistically, recursive portioning is a non-parametric approach to regression, in this case logistic regression.  
We will predict a class Y (aspiration vs. non-aspiration) based on the predictor variables, X1….Xn which can 
be either categorical or continuous.  The main characteristic of this method is that predictor variables are 
“split” and partitions are created so that observations with the same response variable are grouped together.  
After the first split, further splits of variables will occur based on the groups which are made from the prior 
split separately.  The goal is to group observations with the same response class minimizing 
misclassification.  Some of the benefits of using recursive partitioning are that the splits are data driven, 
predictor variables can be used multiple times, and interactions will be included without having to decide 
which interactions are important.  An algorithm (or tree) is obtained that splits the predictor variables until 
each person has been classified as with aspiration or non-aspiration in a terminal node. Pruning of the tree 
will take place by determining a value of the change in misclassification rate which is deemed too small to 
include the next branches on the trees. By splitting the data up into ten sets and choosing one set each 
time, ten-fold cross-validation will estimate the misclassification rate for the tree. The chosen set will be sent 
through a tree developed from randomly choosing nine of the sets. The misclassification for this set will be 
calculated, and performed 10 times until each set has been sent through a tree. An average rate of 
misclassification is developed to determine how well the tree based on all the data will perform on new data.
Sample Size Calculation and Feasibility: Based on our 18 month data from the two medical centers, there 
were a total of 1087 patients who remained on mechanical ventilation for at least 48 hours and lived to be 
discharged to home or self-care. For recursive partitioning, there are no specific sample size calculations. 
However, in a simulated data analysis, a sample size of 200 yielded an area under the curve (AUC) of .75 
for the resultant tree algorithm. To be conservative, we will enroll a total of 225 patients. Based on our 
estimated number of ARF survivors, we will need to obtain consent from only 20.6% of them to achieve our 
enrollment goal. This is a very conservative estimate for obtaining informed consent for research on 
swallowing function.
Additional Considerations: Our primary analysis will develop a CPR for the combined outcome of silent 
and non-silent aspiration. We will also develop a CPR for silent aspiration alone defined as a PAS score =8, 
and a CPR for non-silent aspiration alone defined as a PAS score of 6-7. For each of the five different 
consistencies, the accuracy of the BSE assessment for aspiration will also be compared to the presence of 
aspiration of the FEES examination (PAS ≥6). Sensitivity, specificity, positive and negative predicted values 
will be determined with 95% confidence intervals for each point estimate. Based on a sample size of 225 
patients, the width of each 95% confidence interval point estimate will be 2-4%. 
Statistical analysis for Aim #2: For each outcome and independent variable, a univariate logistic 
regression model will be developed.  If the Wald test for an individual variable in the logistic regression 
model is significant at the p <0.10 level, the variable will be included in a multivariable logistic regression 
model.  ROC curves will be constructed to determine how well the regression models correctly predict 

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whether the subject had the outcome of interest.  Using baseline demographical information, testing for 
confounding will also be assessed to better understand the relationships between independent variables 
and outcomes. Based on the enrollment described in Aim #1, we have powered the univariate comparison 
between our primary independent and dependent variables for these studies. A logistic regression with a 
sample size between 178 and 271 observations achieves 80% power at a 0.05 significance level to detect 
an odds ratio between 2.5 and 3.0. 
Risks and Justifications of Procedures and Data Collection Tools: Risks of the FEES procedure 
include patient discomfort, gagging, vomiting, aspiration, mucosal injury, epistaxis, and an adverse 
reactions to topical anesthetics.12, 15-17   One study of 500 consecutive FEES assessments reported the 
occurrence of minor epistaxis with spontaneous cessation of bleeding in 0.6% of cases.15  Another survey 
of SLPs performing a total of 6000 FEES examinations reported 20 cases of epistaxis (0.3%).18
Vasovagal syncope and laryngospasm, while theoretical concerns, have been shown to occur 
exceedingly infrequently (a total of two and four cases, respectively, ever reported out of all FEES 
procedures ever done).18   None of these reported cases resulted in serious consequences.18   The 3-
WST has been shown to be a safe test in large groups of hospitalized patients.11, 19   Our informed consent 
process will involve a complete discussion of each of these risks, citing reported frequencies of adverse 
events. Due to the risk of breach of confidentiality, we have assured that all data will be collected and 
stored in a safe manner. All data at each site, will be stored on a password protected research-specific 
server, and will not be transferred to any other computer or flash drive. Hard copies of consent forms and 
other forms will be kept in a locked drawer in a locked office at each enrolling site.  Citrix ShareFile, a 
cloud-based, encrypted HIPAA compliant and University of Colorado IT approved application will be used 
to share de-identified FEES video recordings between the two enrolling sites.  ShareFile will be accessible 
only to approved research staff and used for the fidelity and scoring of FEES procedures by investigators.  
Potential Scientific Problems: This study will not determine the accuracy of these diagnostic tests for 
patients who require mechanical ventilation for fewer than 24 hours or with pre-existing or acute central 
neuromuscular disorders. This will affect the applicability of our results to these patient populations. We 
will also not determine the accuracy of the BSE and 3-WST against a VFSS, considered to also be a gold 
standard test to diagnose dysphagia.10   
HUMAN SUBJECTS
Each study participant or a legally authorized representative (LAR) must sign and date an informed consent 
form. Institutional review board approval will be required before any subject is entered into the study. PETAL 
will use a central IRB.
SELECTION OF SUBJECTS
Federal regulations at 45 CFR 46(a)(3) require the equitable selection of subjects. The ICUs will be 
screened to determine if any patient meets inclusion and exclusion criteria. Data that have been collected as 
part of the routine management of the subject will be reviewed to determine eligibility. No protocol-specific 
tests or procedures will be performed as part of the screening process. If any subjects meet criteria for study 
enrollment, then the attending physician will be asked for permission to approach the patient or his/her LAR 
for informed consent. Study exclusion criteria neither unjustly exclude classes of individuals from 
participation in the research nor unjustly include classes of individuals from participation in the research. 
Hence, the recruitment of subjects conforms to the principle of distributive justice. 
JUSTIFICATION OF INCLUDING VULNERABLE SUBJECTS 
The present research aims to investigate the ability of a bedside evaluation to detect aspiration in acute 
respiratory failure survivors.  Due to the nature of acute respiratory failure and its risk factors (eg, sepsis, 
trauma), some patients will have impaired decision-making capabilities. This study cannot be conducted if 
limited to enrolling only those subjects with retained decision-making capacity. Hence, subjects recruited for 
this trial are not being unfairly burdened with involvement in this research simply because they are easily 
available.
INFORMED CONSENT

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Federal regulations 45 CFR 46.111(a)(5) require that informed consent will be sought from each prospective 
subject or the subject’s legally authorized representative (LAR). As we will enroll patients recovering from 
acute respiratory failure we anticipate some consents will be from the subject’s LAR, and thus the remainder 
of this section will focus on LARs. The investigator is responsible for ensuring that the LAR understands the 
risks and benefits of participating in the study, and answering any questions the LAR may have throughout 
the study and sharing any new information in a timely manner that may be relevant to the LAR’s willingness 
to continue the subject’s participation in the trial. The consenter will make every effort to minimize coercion. 
All study participants or their LARs will be informed of the objectives of the study and the potential risks. The 
informed consent document will be used to explain the risks and benefits of study participation to the LAR in 
simple terms before the patient is entered into the study, and to document that the LAR is satisfied with his 
or her understanding of the risks and benefits of participating in the study and desires to participate in the 
study.  The investigator is responsible for ensuring that informed consent is given by each LAR. This 
includes obtaining the appropriate signatures and dates on the informed consent document prior to the 
performance of any protocol procedures and prior to the administration of study agent.
CONTINUING CONSENT
For subjects for whom consent was initially obtained from a LAR, but who subsequently regains decision-
making capacity while in hospital, all sites will obtain formal consent for continuing participation, inclusive of 
continuance of data acquisition. The initial consent form signed by the LAR should reflect that such consent 
will be obtained.
WITHDRAWAL OF CONSENT
Patients may withdraw or be withdrawn (by the LAR) from the trial at any time without prejudice. Data 
recorded up to the point of withdrawal will be included in the trial analysis, unless consent to use their data 
has also been withdrawn. If a patient or LAR requests termination of the trial during the study period, the 
study will be stopped but the patient will continue to be followed up as part of the trial. If a patient or LAR 
withdraws consent during trial treatment, the trial will be stopped but permission will be sought to access 
medical records for data related to the study. If a patient or LAR wishes to withdraw from the trial after 
completion of trial treatment, permission to access medical records for study data will be sought.  
Identification of Legally Authorized Representatives
Many of the patients approached for participation in this research protocol will invariably have limitations of 
decision-making abilities due to their critical illness. Hence, most patients will not be able to provide 
informed consent.  Accordingly, informed consent will be sought from the potential subject’s legally 
authorized representative (LAR).  
Regarding proxy consent, the existing federal research regulations (‘the Common Rule’) states at 45 CFR 
46.116 that “no investigator may involve a human being as a subject in research…unless the investigator 
has obtained the legally effective informed consent of the subject or the subject’s legally authorized 
representative”; and defines at 45 CFR 46 102 (c) a legally authorized representative (LAR) as “an 
individual or judicial or other body authorized under applicable law to consent on behalf of a prospective 
subject to the subject’s participation in the procedures(s) involved in the research.” OHRP defined examples 
of “applicable law” as being state statutes, regulations, case law, or formal opinion of a State Attorney 
General that addresses the issue of surrogate consent to medical procedures. Such “applicable law” could 
then be considered as empowering the LAR to provide consent for subject participation in the research. 
Interpretation of “applicable law” may be state specific and will be addressed by the  IRB.
According to a previous President’s Bioethics Committee (National Bioethics Advisory Committee), an 
investigator should accept as an LAR…a relative or friend of the potential subject who is recognized as an 
LAR for purposes of clinical decision making under the law of the state where the research takes place 
(National Bioethics Advisory Committee (NBAC), 1998). Finally, OHRP has stated in their determination 
letters that a surrogate could serve as a LAR for research decision making if such an individual is authorized 
under applicable state law to provide consent for the “procedures” involved in the research study (Office of 

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Human Research Protections (OHRP), 2002).     
JUSTIFICATION OF SURROGATE CONSENT
According to the Belmont Report, respect for persons incorporates at least two ethical convictions; first, that 
individuals should be treated as autonomous agents, and second, that person with diminished autonomy are 
entitled to protection. One method that serves to protect subjects is restrictions on the participation of 
subjects in research that presents greater than minimal risks. Commentators and Research Ethics 
Commissions have held the view that it is permissible to include incapable subjects in greater than minimal 
risk research as long as there is the potential for beneficial effects and that the research presents a balance 
of risks and expected direct benefits similar to that available in the clinical setting (Dresser, 1999). Several 
U.S. task forces have deemed it is permissible to include incapable subjects in research. For example, the 
American College of Physicians’ document allows surrogates to consent to research involving incapable 
subjects only  “if the net additional risks of participation are not substantially greater than the risks of 
standard treatment.” (American College of Physicians, 1989). Finally, the National Bioethics Advisory 
Committee (NBAC) stated that an IRB may approve a protocol that presents greater than minimal risk but 
offers the prospect of direct medical benefits to the subject, provided that…the potential subject’s LAR gives 
permission…” (National Bioethics Advisory Committee (NBAC), 1998)
Consistent with the above ethical sensibilities regarding the participation of decisionally incapable subjects 
in research and the previous assessment of risks and benefits in the previous section, the present study 
presents a balance of risks and potential direct benefits that is similar to that available in the clinical setting.    
ADDITIONAL SAFEGUARDS FOR VULNERABLE SUBJECTS  
The present research will involve subjects who might be vulnerable to coercion or undue influence. As 
required in 45CFR46.111(b), we recommend that additional safeguards be included to protect the rights and 
welfare of these subjects. Such safeguards might include, but are not limited to: a) assessment of the 
potential subject’s capacity to provide informed consent, b) the availability of the LAR to monitor the 
subject’s subsequent participation and withdrawal from the study; c) augmented consent processes. The 
specific nature of the additional safeguards will be left to the discretion of the central IRB, in conjunction with 
the sites.  
CONFIDENTIALITY
Federal regulations at 45 CFR 46 111 (a) (7) requires that when appropriate, there are adequate provisions 
to protect the privacy of subjects and to maintain the confidentiality of data. To maintain confidentiality, all 
laboratory specimens, evaluation forms, and reports will be identified only by a coded number.  The coded 
number will be generated by a computer, and only the study team will have access to the codes.  All records 
will be kept in a locked, password protected computer.  All computer entry and networking programs will be 
done with coded numbers only.  All paper case report forms will be maintained inside a locked office.  Study 
information will not be released without the written permission of the patient, except as necessary for 
monitoring by the National Heart, Lung, and Blood Institute, and the PETAL Clinical Coordinating Center.
ADVERSE EVENTS
SAFETY MONITORING
Assuring patient safety is an essential component of this protocol. Each participating investigator 
has primary responsibility for the safety of the individual participants under his or her care. The 
Investigators will determine daily if any adverse events occur during the period from enrollment 
through study day 2 or ICU discharge, whichever occurs first.  
The following adverse events will be collected in the adverse event case report forms:

Serious adverse events

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
Nonserious adverse events that are considered by the investigator to be related to study 
procedures or of uncertain relationship 
A clinical study adverse event is any untoward medical event associated with the study procedure in 
humans, whether or not it is considered related to a study procedure.  
Adverse events related to protocol procedures must be evaluated by the investigator. If the adverse event is 
judged to be reportable, as outlined above, then the investigator will report to the medical monitor their 
assessment of the potential relatedness of each adverse event to protocol procedure. Investigators will 
assess if there is a reasonable possibility that the study procedure caused the event, based on standard 
criteria. Investigators will also consider if the event is unanticipated or unexplained given the patient’s 
clinical course, previous medical conditions, and concomitant medications.  
If a patient's participation in the study is discontinued as a result of an adverse event, study site personnel 
must report the circumstances and data leading to discontinuation of treatment in the adverse event case 
report forms.  
SERIOUS ADVERSE EVENTS
Serious adverse event collection begins after the patient or surrogate has signed informed consent and has 
undergone study procedures.  If a patient experiences a serious adverse event after consent, but prior to the 
start of the study, the event will NOT be collected unless the investigator feels the event may have been 
caused by a protocol procedure. 
Study site personnel must alert the medical monitor of any serious and study procedure related adverse 
event within 24 hours of investigator awareness of the event.  Alerts issued via telephone are to be 
immediately followed with official notification on the adverse event case report form. 
As per the FDA and NIH definitions, a serious adverse event is any adverse event that results in one of the 
following outcomes and is not classified as a clinical outcome of acute respiratory failure using the 
definitions noted above:

Death 

A life-threatening experience (that is, immediate risk of dying)

Prolonged inpatient hospitalization or rehospitalization
As per http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm: Report if admission to 
the hospital or prolongation of hospitalization was a result of the adverse event. Emergency room 
visits that do not result in admission to the hospital should be evaluated for one of the other serious 
outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; 
other serious medically important event).

Persistent or significant disability/incapacity
As per http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm: Report if the adverse 
event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., 
the adverse event resulted in a significant, persistent or permanent change, impairment, damage or 
disruption in the patient's body function/structure, physical activities and/or quality of life.
Important medical events that may not result in death, be life-threatening, or require hospitalization may be 
considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize 
the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this 
definition.
Serious adverse events will be collected during the first 2 study days or until ICU discharge, whichever 

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occurs first, regardless of the investigator's opinion of causation. Thereafter, serious adverse events are not 
required to be reported unless the investigator feels the events were related to either study drug or a 
protocol procedure.

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APPENDIX: Case Report Forms
Part 1: BSE Direct Physical Examination
Facial symmetry
Normal
Asymmetric
Not Done
  
Lip seal/strength
Complete seal
Reduced Seal/ Weak
Not Done
Lip movements
Normal
Slow, uncoordinated
Not Done
Tongue strength/ ROM
Normal/complete
Weak/Reduced
No movement
Not Done
Tongue  movements
Normal
Slow, uncoordinated
Not Done
Dentition
Adequate
Missing teeth
Dentures Edentulous
Not Done
Saliva
Normal
Drools at times Drools constantly
Not Done
Palate/velar elevation
Adequate
Incomplete
Not Done
Baseline voice
Normal
Aphonic  Hoarse
Wet, gurgly
Not Done
Baseline Breathing sounds
Normal
Wet
Hoarse/noisy Stridorous Not Done
Respiratory rate
(count breaths for 20 seconds and 
then multiple by 3)
__________(breaths/min)  or Not performed
Volitional cough
Strong
Weak 
 Absent
Not done
Volitional cough with peak flow 
meter
___________(liters/min)  or Not performed

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Part 2:  Bolus administration
Study ID:                                     Date:                                        Time:
Note: Determine signs and symptoms of aspiration within 10 seconds after swallowing
Ice Chips
(1/2 tsp)
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Hyolaryngeal excursion
Can check 1, 2, or 3 signs 
__ Normal
or
__Delayed/Slow
___ Reduced
_____ Multiple swallows
Ice Chips
(full tsp)
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Nectar
Thick
(5 ml)
Bolus given:
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or

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YES      NO
Stethoscope used 
for auscultation 
YES      NO
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Nectar
Thick
(15 ml)
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Nectar
Thick
2 ounce Patient 
Controlled
With a Straw
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Puree
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
Oral Phase
Can check 1,2, 3, or 4 signs   
Hyolaryngeal excursion
Can check 1, 2, or 3 signs 

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(applesauce)
(5 ml)
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
__ Normal
or
__Delayed/Slow
___ Reduced
_____ Multiple swallows
Puree
(applesauce)
(15 ml)
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Thin Liquid
(water)
(5 ml) or a tsp
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:

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              (Greater than 10%)
_________________
Thin Liquid
(water)
(15 ml)
Bolus given:
YES      NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Thin Liquid
(Water)
2 Oz 
Patient controlled 
With a straw
Bolus Given:
YES    NO
Stethoscope used 
for auscultation 
YES      NO
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)
___Other impairment
Explain:
_________________
Solid
(1/4 graham 
cracker)
Bolus given:
YES      NO
Stethoscope used 
Signs of Aspiration
Can check 1,2, 3, 4, or 5 signs 
___ No aspiration
or
___ Cough/Choking
___  Throat Clearing
___Change in voice
Oral Phase
Can check 1,2, 3, or 4 signs   
__  Normal
or
__  Prolonged/Slow/Delayed/Cued
__  Disorganized 
__  Weak (oral residual)

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for auscultation 
YES      NO
___Change in Breath sounds
____ Change in Pulse Ox
              (Greater than 10%)
___Other impairment
Explain:
_________________
Part 3.  3 oz Water Swallow Test (Yale Protocol)  
Patient is given a cup with 3 oz water. He is asked to drink the entire amount, slowly and 
steadily, but without stopping.(use your judgment).  He can drink from the cup with a 
straw and the SLP can hold the cup or straw
Was the 3 oz water test performed?      YES     NO
If yes complete the following table.
Patient 
stopped
 1+ times?
Yes
No
Patient failed
 to drink the 
entire amount?
Yes
No
Cough/Choking?
Yes
No
Change in 
Voice??
Yes
No
Change in
 Breath Sounds?
Yes
No
 No signs
 of aspiration
Yes
No
RESULTS of 3 oz water test?                  PASS   FAIL
Pass= drinks the entire amount without stopping (use your judgment), and without 
coughing, choking during or immediately after completion.
Fail = does not finish the total amount, stops 1+ times (for more than a few seconds), or 
has overt signs of aspiration immediately after swallowing
SUMMARY OF CLINICAL EXAM
Results:
Dysphagia detected? 
Yes/no (oral or pharyngeal)
Aspiration detected? 
Yes/no
Diet texture recommendations (circle one)
Solids:
regular
(NDD3)
mechanical (NDD2)
puree (NDD1)
npo
Liquids
thin
nectar
honey
npo

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Part 4:  Scoring Sheet for the FEES Testing
R 21 FEES Evaluation Form
Study ID:                                     Date:                                        Time:
MAKE SURE THE ENTIRE EXAMINATION IS VIDEOTAPED
Afrin spray used:            YES              NO
Topical lidocaine used:   YES              NO
Velar Closure
(hiss like a snake)
Complete  Incomplete
 N/A
Base of Tongue Retraction
(Paul is tall)
Present
Absent
 N/A
Right Vocal Cord/Arytenoid Mobility
None   Mild
Moderate
Severe
 N/A
Left Vocal Cord/Arytenoid Mobility
None   Mild
Moderate
Severe
 N/A
Glottic Closure 
(breath hold, cough, phonation)
Complete  Incomplete
 N/A
Laryngeal Elevation/ Arytenoid lift
(glide with an “eee”
Present
Absent
 N/A
Right Pharyngeal Wall Medialization
Complete
Reduced
Absent
 N/A
Left  Pharyngeal Wall Medialization
Complete
Reduced
Absent
 N/A
Epiglottic Retroflexion 
(during swallow)
Complete
Reduced
Inconsistent
Absent
 N/A
Granuloma Formation
None   Mild
Moderate
Severe
 N/A
Upper Airway Edema
None   Mild
Moderate
Severe
 N/A

COMIRB # 12-0184
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Protocol version 3, 07/09/2015
Right Laryngeal Sensation
touch on the aryepiglottc fold, if no 
sensation then repeat x1;
None   Mild
Moderate
Severe
 N/A
Left Laryngeal Sensation
touch on the aryepiglottc fold, if no 
sensation then repeat x1;
None   Mild
Moderate
Severe
 N/A

COMIRB # 12-0184
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Protocol version 3, 07/09/2015
Ice Chips
(1/2 tsp)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Determined
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Ice Chips
(full tsp)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Nectar
Thick
(5 ml) or 1 tsp
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
During
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply

COMIRB # 12-0184
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Protocol version 3, 07/09/2015
Swallow
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Nectar
Thick
(15 ml)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Nectar
Thick
2 ounce Patient
Controlled
With a Straw
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None

COMIRB # 12-0184
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Protocol version 3, 07/09/2015
Puree
(applesauce)
(5 ml)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Puree
(applesauce)
(10 ml)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Thin Liquid
(Water)
(5 ml)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels

COMIRB # 12-0184
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Protocol version 3, 07/09/2015
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Thin Liquid
(Water)
(15 ml)
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Thin Liquid
(Water)
2 Oz 
Patient 
controlled 
With a straw
Bolus given:
YES      NO
PAS score
_________
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
Swallowing 
Onset Time
________
Not Done
Incomplete bolus clearance
Yes
No
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
Solid
(1/4 graham 
PAS score
_________
Swallowing 
Onset Time
Incomplete bolus clearance
Yes
No

COMIRB # 12-0184
Page 29
Protocol version 3, 07/09/2015
cracker)
Bolus given:
YES      NO
Not Determined
If penetration (2-5):
Before 
Swallow
During
Swallow
After Swallow
If aspiration (6-8)
Before 
Swallow
During
Swallow
After Swallow
________
Not Done
Not Done
Residue location:
Circular all that apply
BOT
valleculae
Lateral
channels
piriforms
Laryngeal 
vestibule
Response to residue:
Spontaneous 
clearing
None
3 oz Water Swallow Test:  
Patient is given a cup with 3 oz water. He is asked to drink the entire amount, slowly 
and steadily, but without stopping.  He can drink from the cup or a straw and the SLP 
can hold the cup or straw
Was the 3 oz water test performed?      YES     NO
If yes complete the following table.
Did the 
patient 
stop 1 + 
times
Yes
No
Did the patient 
finish the 
entire amount
Yes
No
Cough/Choking
Yes
No
Change in 
Voice
Yes
No
Wet Breath 
Sounds
Yes
No
No signs of 
aspiration
Yes
No
RESULTS of 3 oz water test?                  PASS   FAIL
Pass= drinks the entire amount without stopping (use your judgment), and without 
coughing, choking during or immediately after completion.
Fail = does not finish the total amount, stops 1+ times (for more than a few seconds), or 
has overt signs of aspiration immediately after swallowing

COMIRB # 12-0184
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