The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study
Phase: NA
Conditions: Mechanical Ventilation Complication
Sponsor: Vanderbilt University Medical Center

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
 
 
 
 
 
Endotracheal Tube Securement Study: The Effect of Adhesive Versus Endotracheal Tube 
Fastener in Critically Ill Adults 
 
 
Janna S. Landsperger, ACNP-BC 
Department of Medicine 
Division of Allergy, Pulmonary, and Critical Care Medicine 
Vanderbilt University School of Medicine 
 
Todd W. Rice, MD, MSc 
Department of Medicine 
Division of Allergy, Pulmonary, and Critical Care Medicine 
Vanderbilt University School of Medicine 
 
 
 
 
 
 
 
 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
Table of Contents: 
 
Study Schema 
1.0 
Study Summary 
2.0 
Background 
3.0 
Rationale, Aims, and Hypotheses 
4.0 
Study Description 
5.0 
Inclusion/Exclusion Criteria 
6.0 
Enrollment/Randomization 
7.0 
Study Procedures 
8.0 
Risks and Benefits 
9.0 
Adverse Events 
10.0 
Study Withdrawal/Discontinuation 
11.0 
Statistical Considerations 
12.0 
Privacy/Confidentiality Issues 
13.0 
Follow-up and Record Retention 
14.0 
References 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
1.0 Study Summary 
Title: Endotracheal Tube Securement Study: The Effect of Adhesive Tape Versus Endotracheal 
Tube Fastener on Lip Integrity, Tube Dislodgement, and Ventilator Associated Pneumonia in 
Critically Ill Adults 
- A single center randomized controlled trial of endotracheal tube securement with adhesive 
tape versus endotracheal tube fastener in the incidence of lip ulcers, tube dislodgement, and 
ventilator associated pneumonia.  
Study Site:  Vanderbilt University Medical Center Nashville, TN 
Background:  During endotracheal intubation there are many potential complications including 
laryngeal trauma, bronchospasm, hypotension, airway perforation, and vertebral column injury. 
Following intubation for mechanical ventilation, there are several techniques to secure the 
endotracheal tube.  The optimal stabilization method in reducing complications is unknown. We 
propose a randomized controlled trial to compare the effect of adhesive tape versus 
endotracheal tube fastener on complications including lip ulcers, endotracheal tube 
dislodgement, and ventilator associated pneumonia among critically ill adults requiring 
intubation and mechanical ventilation.  
Primary Aim:  
• To compare the effect of adhesive tape versus endotracheal tube fasteners on 
the incidence of lip ulcers, tube dislodgement, and ventilator associated 
pneumonia among critically ill adults undergoing endotracheal intubation 
 
Primary Hypothesis: 
• The use of an endotracheal tube fastener will reduce the incidence of lip ulcers, 
tube dislodgement, and ventilator associated pneumonia among critically ill 
adults undergoing endotracheal intubation 
Inclusion Criteria: 
1. Patient is admitted to an ICU at Vanderbilt University Medical Center 
2. Patient requires intubation and mechanical ventilation 
3. Intubated for less than 12 hours before enrollment in the study 
4. Patient anticipated to be intubated 24 hours or longer 
5. Age > 18 years 
 
Exclusion Criteria: 
1. Presence of oral mucosa or facial skin breakdown before study enrollment 
2. Nasotracheal intubation 
3. Patients with documented allergy to tape 
4. Patient has facial anatomy which prevents the use of endotracheal tube fastener 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
5. Prisoners 
6. Pregnant patients 
Consent:  Given that both techniques for securing endotracheal tubes are used in practice, 
appear to be arbitrarily chosen by the RT or medical team, and that there is a lack of 
established risk or benefit between the two techniques, this trial poses no increased risk 
beyond usual ICU care to the patients.  Also, over 90% of patients undergoing endotracheal 
intubation in the ICU cannot consent for the procedure itself and choosing a securement 
strategy is time-sensitive as endotracheal tube securement must occur at the time of 
intubation, therefore it is impractical to obtain informed consent for research prior to the 
procedure.  Given the minimal risk interventions and impractability of informed consent, a 
waiver of informed consent will be requested. 
Randomization:  Using opaque envelopes available in the patient care area participating in the 
study, participants will be randomized 1:1 to adhesive or endotracheal tube fastener 
Study Interventions:  
• Endotracheal tube securement 
o Adhesive Tape: (1) Use skin preparation pad (tincture benzocaine) to 
prepare area over cheeks and upper lip where adhesive tape will be 
secured (2) Use tape to tape approach to decrease adhesiveness of tape 
to back of neck / hair area.  (3) Secure tape around patient’s neck. (4) 
Encircle the adhesive tape around the tube and fix to the maxilla about 
the upper lip and down the lower lip.  
o Endotracheal tube fastener: (1) Place upper lip stabilizer so it rests on 
skin between nose and lip; place skin barrier pads on cheeks. (2) Secure 
ETT wrap with non-slip grippers and one-click security clamp. (3) Position 
gliding tube shuttle; reposition as needed for oral care and pressure 
relief.  
o Repositioning: Frequency of repositioning of endotracheal tube in both 
groups will be left to the applicable ICU protocol (or discretion of the 
provider if no applicable protocol) and will be documented accordingly. 
Primary Endpoint (All endpoints are collected non-invasively and are already a part of clinical 
data obtained in usual ICU care at the bedside or in the medical record):   
• Composite of any of: presence of lip ulcer, endotracheal tube dislodgement, or 
facial skin tears from the time of randomization to the earlier of death or 48 
hours after extubation 
Secondary Endpoints: 
• Presence of Lip Ulcer 
• Endotracheal tube dislodgement  
• Ventilator associated pneumonia incidence 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
• Facial skin tears 
• Ventilator-free days 
 
2.0 Background 
 
2.1 Complications of endotracheal tube securement 
Effective endotracheal tube securement is imperative in providing safe mechanical 
ventilation. Various techniques have been utilized to ensure endotracheal tube 
stabilization in order to maintain a patent airway and prevent complications. One 
common complication of endotracheal tube securement is lip ulcers.  The development 
of lip ulcers is not rare and is associated with increased financial burden and potentially 
increased length of stay. Endotracheal tube dislodgement is another common 
complication of tube securement. It is imperative for the tube to be correctly positioned 
to maintain optimum airway passage and promote effective mechanical ventilation. If 
the tube is not secured corrected, it can become dislodged which may result in 
unplanned extubation, bronchospasm, and tracheal injury.  Additionally, endotracheal 
intubation and mechanical ventilation is associated with ventilator associated 
pneumonia. Proper oral hygiene is essential in decreasing the incidence of ventilator 
associated pneumonia. Utilizing an endotracheal tube securement technique that 
enables providers to perform oral hygiene is imperative. It is thought that modifying 
endotracheal tube securement technique could reduce these complications. 
 
3.0 Rationale, Aims, and Hypotheses 
In order to determine the effect of adhesive versus endotracheal tube fasteners on prevalence 
of lip ulcers, endotracheal tube dislodgement, and ventilator associated pneumonia among 
intubated critically ill patients, a randomized trial is needed.  
 
Study Aims: 
Primary: 
• To compare the effect of adhesive tape versus endotracheal tube fasteners on 
adverse effects (lip ulcers, endotracheal tube dislodgement, or facial skin tears) 
among critically ill adults undergoing endotracheal intubation 
 
Secondary:   
• To compare the effect of adhesive tape versus endotracheal tube fasteners on 
ventilator-free days among critically ill adults undergoing endotracheal 
intubation 
 
 
Study Hypotheses: 
Primary:  

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
• The use of an endotracheal tube fastener will reduce the incidence of any of lip 
ulcers, endotracheal tube dislodgement, or facial skin tears among critically ill 
adults undergoing endotracheal intubation 
 
Secondary:   
• The use of endotracheal tube fastener will reduce the incidence of endotracheal 
tube dislodgement, ventilator associated pneumonia, and facial skin tears among 
critically ill adults undergoing endotracheal intubation 
 
• The use of endotracheal tube fastener will increase the number of ventilator-
free days among critically ill adults undergoing endotracheal intubation 
 
4.0 Study Description 
In order to address the aims outlined above, we propose a randomized trial evaluating the 
impact of adhesive tape versus endotracheal tube fastener on the incidence of lip ulcers, 
endotracheal tube dislodgement, ventilator associated pneumonia, and facial skin tears among 
critically ill adults undergoing endotracheal intubation. Patients admitted to the study ICU who 
are deemed by their clinical team to require intubation and fulfill inclusion criteria without 
meeting exclusion criteria will be enrolled and randomly assigned to adhesive tape versus 
endotracheal tube fastener. If patients were intubated prior to admission to the intensive care 
unit and the intubation time was less than 12 hours from the time of admission, they will be 
included in the study.  Data will be collected at the time of intubation and prospectively from 
the medical record in order to determine the effect of the assigned intervention on short- and 
long-term outcomes.  All data are collected non-invasively and are already a part of clinical data 
obtained in usual ICU care at the bedside or in the medical record.  No additional data will be 
collected that are not observed at the bedside or obtained from the medical record. 
5.0 Inclusion and Exclusion Criteria 
5.1 Inclusion Criteria 
We will include endotracheal tube securement events in which:  
1. Patient is admitted to the intensive care unit at Vanderbilt University Medical 
Center. 
2. Planned procedure is endotracheal intubation and mechanical ventilation OR 
3. Patient is intubated prior to arrival, however the intubation occurred less than 12 
hours prior to admission to the intensive care unit 
4. Patient is likely to be intubated > 24 hours. 
5. Age > 18 years old  
 
5.2 Exclusion Criteria 
We will exclude airway management events in which: 
1. Patient has presence of oral mucosa or facial skin breakdown before study 
enrollment 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
2. Patient will require nasotracheal intubation 
3. Patients with documented allergy to tape 
4. Patient who have facial anatomy which prevent the use of endotracheal tube 
fastener 
5. Prisoners 
6. Pregnant patients 
7. Patient who the team feels must have either adhesive tape or endotracheal tube 
skin fasteners as the securement device  
 
6.0 Enrollment/Randomization 
6.1 Study Sites: ICU at Vanderbilt University Medical Center 
6.2 Study Population:  The study population will be all critically ill adults admitted to an 
ICU service for whom the clinical team has decided to perform endotracheal 
intubation or for whom endotracheal intubation has been performed within 12 
hours prior to admission.  Patients will be excluded if they were intubated greater 
than 12 hours prior to admission, if they have oral mucosa or facial skin breakdown 
before enrollment, if they require nasotracheal intubation, or have a documented 
allergy to tape. 
6.3 Enrollment:  All patients will be enrolled at the time the clinical team decides that 
intubation is required and the patient meets inclusion but no exclusion criteria.  If 
the patient arrives in the MICU already intubated, but has been intubated less than 
12 hours and does not have exclusion criteria, they will be eligible for randomization 
as soon as possible (but must occur within 12 hours of the intubation) when their 
endotracheal tube is undergoing securement. 
6.4 Consent: Because the intervention studied (1) is FDA approved and used according 
to its FDA approval as a part of routine care, (2) is an intervention the patients would 
arbitrarily be exposed to even if not participating in the study, and (3) is an 
equivalent option from the perspective of the clinical provider (otherwise patient is 
excluded), we feel the waiver of consent involves no more than minimal risk. 
Additionally, obtaining informed consent in the study would be impractical.  
Endotracheal intubation of acutely ill patients is frequently a time-sensitive 
procedure.  Despite the availability of a formal informed consent document for the 
procedure itself, time allows discussion of risks and benefits in less than 10% of 
airway management events in the ICU. 
Because the study interventions represent minimal risk, would not adversely affect 
the welfare or privacy rights of the participant, and consent would be impracticable, 
we will request a waiver of informed consent. Information regarding the study will 
be available for patients and families. 
6.5 Randomization: Computerized randomization using permuted blocks of two, four, or 
six will be conducted in order to generate a series of study assignments deliberately 
exceeding the planned enrollment number.  Study assignments will be placed in 
opaque randomization envelopes and will be available to operators in the ICU at 
VUMC.  Study group assignment will remain concealed to study personnel and 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
operators until after the decision has been made to enroll the patient in the study.  
Once it has been determined by the treating team that intubation is required, (or 
maintenance of endotracheal tube securement in patients intubated less than 12 
hours prior to admission) the operator will open the envelope and follow the 
assignment of either adhesive tape or endotracheal tube fastener.  
 
7.0 Study Procedures 
7.1 Study Interventions 
7.1.1 Endotracheal Tube Securement 
Once the envelope is opened and group assignment known, the clinical 
team will either secure the endotracheal tube with either adhesive tape 
or the endotracheal tube fastener.   In patients randomized to adhesive 
tape, the respiratory therapist will secure the endotracheal tube with 
adhesive tape as demonstrated in figure 1.  In patients randomized to 
endotracheal tube fastener, the respiratory therapist will secure the 
endotracheal tube with the Hollister endotracheal tube fastener per the 
manufacturer’s instructions (demonstrated in figure 2).    
7.1.2 Endotracheal Tube Repositioning 
Prior studies investigating endotracheal tube securement techniques 
require that the endotracheal tube is repositioned and retaped every 24 
hours (1,2). However, due to the pragmatic design and intent of this 
protocol, the endotracheal tube will not routinely be repositioned 
specifically as part of the study protocol. The tube will be repositioned as 
needed according to ICU policy or protocols or at the discretion of the 
provider, bedside nurse, or respiratory therapist.  
7.1.3 Oral hygiene 
Oral hygiene will be performed every 12 h and oral moistening every 2 
hours based on policy of the ICU. 
 
8.0 Data Collection 
All data will be collected non-invasively and will already be a part of clinical data obtained in 
usual ICU care at the bedside or in the medical record.  No additional data will be obtained 
beyond that which is obtained by bedside observation and from the electronic medical 
record. 
Baseline: Age, gender, height, weight, race, active medical problems at the time of intubation, 
active comorbidities complicating intubation, indication for intubation, whether it is a 
reintubation, whether the face was soiled during the intubation  
 
Periprocedural: Depth of tube as measured at lip line and position in mouth (ie 22 cm at the lip, 
midline) at time of securement 
In-Hospital Outcomes: days on mechanical ventilator, ICU mortality, mortality for ventilator 
free days, oral mucosa assessment, facial skin integrity assessment, frequency of endotracheal 
tube repositioning, endotracheal tube dislodgements – defined as either complete 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
dislodgement of the endotracheal tube (i.e. accidental extubation) or needing to reposition the 
endotracheal tube more than 1 cm (i.e. need to pull ETT back 2+ cm or move it down 2+ cm). 
 
The following study endpoints will be collected if they occur anytime between randomization 
and the earlier of death, hospital discharge, tracheostomy placement, or 48 hours after 
extubation:  lip ulcers, facial skin tears, tube dislodgement, and ventilator associated 
pneumonia. 
 
Ventilator-free days will be collected from the time of randomization through study day 28.  In 
order to get credit for a ventilator-free day, a patient must be both alive and free of mechanical 
ventilation.  Patients who are extubated and reintubated will only be credited with being free of 
mechanical ventilation for days after the last extubation.  Patients who die before study day 28, 
regardless of whether or not they ever achieved unassisted breathing, will be assigned zero 
ventilator-free days.  Patients who are still on the ventilator at study day 28 will also receive 
zero ventilator-free days.  Patients who are discharged from the hospital prior to study day 28 
free of mechanical ventilation will be assumed to remain free of mechanical ventilation through 
study day 28.  Patients who are discharged from the hospital prior to day 28 on mechanical 
ventilation will try to be followed at the discharge location for date of extubation – however, if 
the date is not able to be obtained, they will be assumed to have zero ventilator free days in 
the analysis. 
 
9.0 Risk and Benefits 
In patients for whom the treating team has decided endotracheal intubation is required, 
there are currently no established risks or benefits to endotracheal tube securement with 
adhesive tape or endotracheal tube fastener.  Additionally, previous studies of endotracheal 
tube securement of critically ill adults suggest that in routine care, respiratory therapists 
arbitrarily decide to use adhesive tape or endotracheal tube fastener.  At this time, there is 
no reason to believe that participation in this study would expose patients to greater 
medical risks or benefits than those experienced by critically ill patients requiring 
endotracheal intubation and securement as a part of routine care. The greater benefit of 
the study would be to improve understanding of safe and effective endotracheal tube 
securement for critically ill patients. 
A potential risk to patients participating in this study involves the collection of protected 
health information (PHI).  In order to limit the associated risks, the minimum amount of PHI 
necessary for study conduct will be collected.  After collection, the data will be stored in a 
secure online database (REDCap) only accessible by the investigators.  After publication, a 
de-identified database will be generated to protect participant privacy. 
 
 
10.0 
Safety Monitoring and Adverse Events: 
10.1 
Safety Monitoring  
This study will take place in the environment of the intensive care unit. At the time of the study 
intervention, the patient will have in the room a critical care nurse and respiratory therapist.  

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
Additionally, there will be continuous invasive or non-invasive monitoring.  Additionally, study 
personnel will readily be available to answer questions at any time during the study course.  
Even after randomization if any healthcare provider participating in the endotracheal tube 
securement study believes that the study interventions cannot be performed for the safe 
performance of the procedure or the safety of the patient, the study intervention is halted and 
the patient has the endotracheal tube secured in the manner which the clinical team judges to 
be safest. 
 
 
10.2 
Adverse Events 
An adverse event is defined as any untoward medical occurrence in a clinical 
investigation participant administered an intervention that does not necessarily have to have a 
causal relationship with this treatment.  An adverse event therefore can be any unfavorable 
and unintended sign, symptom, or disease temporally associated with the use of an 
intervention, whether or not the incident is considered related to the intervention. 
 
A serious adverse event (SAE) is defined as any unexpected and untoward medical 
occurrence that is probably or possibly related to the study and meets any of the following 
criteria: 
a. Results in death 
b. Is life-threatening (defined as an event in which the participant was at risk of death at 
the time of the event and NOT an event that hypothetically might have caused death if 
it would have been more severe) 
c. Requires inpatient hospitalization 
d. Prolongs an existing hospitalization 
e. Results in persistent or significant disability or incapacity 
f. Results in a congenital anomaly or birth defect 
g. Important medical event that requires an intervention to prevent any of a-f above. 
 
 
The Principal Investigator will be responsible for overseeing the safety of this trial on a 
daily basis.  She will be available at any time for questions from the bedside nurses or 
respiratory therapists, who will also be monitoring the patients continuously for adverse events 
and serious adverse events.  Serious and unexpected adverse events associated with study 
interventions will be recorded in a case report form in the study record and reported to the IRB 
within 10 business days.   
 
11.0 
Study Withdrawal/Discontinuation 
 
Patients can be withdrawn from study participation in the following circumstances: 
• The investigator or medical team decides that the patient should be withdrawn 
for safety considerations. 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
• There is a significant protocol violation in the judgment of the PI. 
 
The reason and date of every withdrawal will be recorded in the patient study records.  Follow-
up will be performed for all patients who discontinue due to an adverse event or any other 
safety parameter.  Follow-up will also be performed for all patients who end participation in the 
protocol for another reason, but who also have an adverse event or other safety parameter 
that could have led to discontinuation.  Follow-up will be conducted until the condition has 
resolved, until diagnosis of the adverse event or safety parameter is deemed chronic and 
stable, or as long as clinically appropriate.  This follow-up will be documented in the patient 
study record as well.   
 
12.0 
Statistical Considerations 
12.1 
Sample Size Determination 
We estimated the incidences of tube dislodgement to be 20 per 1000 ventilator days and the 
incidence of lip ulcer development in the previous 12 months was 1.1 per 1000 ventilator days.  
Using the sum of these overall incidences of 21.1 per 1000 ventilator days and a standard 
deviation of 15 per 1000 ventilator days, we calculated a need for 142 patients in each arm to 
detect a clinically meaningful change of 5 episodes per 1000 ventilator days with 80% power at 
a two-sided alpha level of 0.05. We plan to enroll 500 patients which would allow for a 5.6% 
dropout or loss to follow-up rate. We used PS software to calculate the sample size. 
 
12.2 
Statistical Analysis 
 
Analysis principles 
• Primary analysis will be conducted on an intention-to-treat basis (patients with protocol 
violations are analyzed per the assigned treatment arm). 
• All hypothesis tests will be two sided, with an α of 0.05 unless otherwise specified. 
• All analyses will be unadjusted unless otherwise specified. 
• Subgroup analyses will be performed irrespective of treatment efficacy. 
 
Trial profile:  
• We will present a Consolidated Standards of Reporting Trials diagram as Figure 1 to 
detail the movement of patients through the study. This diagram will include total 
number of patients meeting inclusion criteria, number excluded and reason for 
exclusion, number enrolled and randomized in the study, number followed, and number 
analyzed. 
12.3 
Baseline Characteristics 
 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
To assess randomization success, we will summarize in Table 1 the distribution of baseline 
variables across the study arms. Categorical variables will be reported as frequencies and 
percentages and continuous variables as either means with SDs or medians with interquartile 
ranges. Variables reported will include Demographics (age, gender, race, BMI); Indication for 
intubation; Active illnesses at the time of intubation; Severity of Illness (APACHE II score, blood 
pressure); Location of intubation (ICU, ED, OSH) 
 
12.4 
Primary Analyses 
 
The primary endpoint will be the continuous variable of incidences of lip ulcers, tube 
dislodgement, or ventilator associated pneumonia per 1,000 ventilator days.  The differences 
between the two groups will be compared using the Mann-Whitney U test. All other 
comparisons will be considered secondary analyses.   
 
12.5 
Secondary Analyses 
 
Analysis of Secondary and Tertiary Outcomes. 
We will conduct unadjusted analysis examining the treatment effect of endotracheal tube 
securement method on each of the pre-specified secondary and tertiary outcomes.  Continuous 
outcomes will be compared with the Mann-Whitney U test and categorical variables with the 
Chi-square or Fisher Exact testing as appropriate. 
Subgroup Analyses. 
We will conduct unadjusted analysis examining the treatment effect of endotracheal tube 
securement technique on incidence of lip ulcers, tube dislodgement, and VAP in each of the 
pre-specified subgroups.  Data will be presented as odds ratios and 95% confidence intervals for 
categorical variables and as mean differences and 95% confidence intervals for continuous 
variables. 
 
12.6 
Presentation of Statistics 
 
Continuous variables will be described as mean and standard deviation or median and 25th 
percentile – 75th percentile or bootstrapped 95% confidence intervals as appropriate.  
Categorical variables will be given as percentage and number.  All between-group comparisons 
with continuous variables will be performed using Mann-Whitney U tests and Chi-square or 
Fisher’s exact test for categorical variables 
 
13.0 
Privacy/Confidentiality Issues 
 
At no time during the course of this study, its analysis, or its publication will patient 
identities be revealed in any manner.  The minimum necessary data containing patient or 
provider identities will be collected.  All patients will be assigned a unique study ID number for 

Principal Investigator: Janna Landsperger, ACNP-BC 
Study Title: Adhesive Versus Endotracheal Tube Fastener  
Institution: Vanderbilt University Medical Center 
 
Version Date: 3/21/2018 
tracking.  Data collected from the medical record will be entered into the secure online 
database REDCap.  Hard copies of the data collection sheet completed at the time of the airway 
management event will be stored in a locked file cabinet in a locked room until after the 
completion of enrollment and data cleaning.  Once data are verified and the database is locked, 
all hard copies of data collection forms will be destroyed.  All data will be maintained in the 
secure online database REDCap until the time of study publication.  At the time of publication, a 
de-identified version of the database will be generated. 
 
14.0 
Follow-up and Record Retention 
 
Patients will be followed after enrollment for 28 days or until hospital discharge, whichever 
occurs first.  Data collected from the medical record will be entered into the secure online 
database REDCap.  Hard copies of the data collection sheet completed at the time of the airway 
management event will be stored in a locked room until after the completion of enrollment and 
data cleaning.  Once data are verified and the database is locked, all hard copies of data 
collection forms will be destroyed.  All data will be maintained in the secure online database 
REDCap until the time of study publication.  At the time of publication, a de-identified version 
of the database will be generated. 
 
15.0 
References 
 
1. Barnason S, Graham J, Wild MC, Jensen LB, Rasmussen D, Schulz P, Woods S, Carder B. 
Comparison of two endotracheal tube securement techniques on unplanned extubation, 
oral mucosa, and facial skin integrity. Heart Lung. 1998 Nov-Dec;27(6):409-17. 
2. Mohammad H, Hassan M. Endotracheal tube securements:  Effectiveness of three 
techniques among orally intubated patients.  Egyptian Journal of Chest Diseases and 
Tuberculosis. 2015 64, 183-196. 
3. Zaratkiewicz S, Teegardin C. Retrospective Review of the Reduction of Oral Pressure 
Ulcers in Mechanically Ventilated Patients: A Change in Practice. Crit Care Nurs Q. 2012 
35 (3) 247-254. 
4. Carlson J, Mayrose J, Krause R, Jehle D. Extubation force: tape versus endotracheal tube 
holders, Ann. Emerg. Med. 50 (6) 2007. 686-691.  
5. Shimizu T, Mizutani T, Yamashita S, Hagiya K, Tanaka M. Endotracheal tube extubation 
force: Adhesive tape versus endotracheal tube holder. Respiratory Care. 2011. 56 (11) 
1825-1829. 
6. Anne G, Hughes D, Cook R, Henson R, et al. Best ractice in stabilization of oral 
endotracheal tubes: a systematic review. Austr. Crit. Care 18 (4). 2005 158-165.