Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
Phase: NA
Conditions: Intubation
Sponsor: Hollister Incorporated

 
 
Clinical Protocol: 5855-I 
Assessment of 
 ET Tube Fastener  
 
 
Company Confidential 
 
i 
Protocol 5855-I 
 
 ET Tube 
Fastener  
 
Protocol Version Date: April 14, 2017 
Protocol Number: 5855-I 
Company Confidential: No portion of this work may be reproduced in whole or in part without the express 
written permission of Hollister Incorporated. This document contains confidential information for use only 
by individuals participating in the study. This document should be maintained in a secure location and 
should not be copied or made available for review by any unauthorized person or firm. Copyright 2017 
Hollister Incorporated. 
Caution: Investigational device, limited by Federal (US) and Canadian law to investigational use. 
(if applicable) 
 
 
 
 
 
Assessment of

 
 
Clinical Protocol: 5855-I 
Assessment of 
 ET Tube Fastener  
 
 
Company Confidential 
 
ii 
1.0 STUDY SYNOPSIS 
Name and address of Sponsor: 
Hollister Incorporated 
 
 
 
 
 
2000 Hollister Drive 
 
 
 
 
 
Libertyville, IL 60048  
 
 
 
 
 
USA 
 
Hollister Study Lead: 
 
 
 
Investigator(s)/Study Center(s): 
United States 
 
 
Objective(s):  
The objective of this study is to assess the acceptability and usability of the study product during 
use. 
 
Study Design: 
This is a multiple site prospective assessment of the study product in the ICU setting.   
 
Study Period: 
The study is comprised of each subject wearing one study product until the study product either 
needs to be changed or is no longer required by the subject. 
 
Target Number of Subjects:   
The sample size for this study is at least thirty (30) subjects. 
 
Eligibility Criteria: 
Study subjects who meet the inclusion and exclusion criteria are recruited by the Investigator or 
designee from the patient population requiring endotracheal tube care with subglottic suctioning.  
Subjects or their authorized representative must be willing to sign an informed consent document 
and comply with study parameters. 
 
Study Product: 
The 
 is designed to hold a standard or subglottic ET tube and 
help reduce the potential for occlusion (blockage) of the tube.  In this study, the study product 
holds only ET tubes with subglottic suctioning capability sizes 6.0-8.0mm. 
 
Statistics Methods: 
Study data will be presented in their entirety or summarized using descriptive statistics. No 
hypothesis tests or other statistical analyses are planned. 
 
Sample Size and Power: 
A sample size of 30 subjects was chosen based on a literature review of two comparable sample 
size studies. 

 
 
Clinical Protocol: 5855-I 
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Table of Contents 
 
 
1.0 
STUDY SYNOPSIS ................................................................................................................. ii 
2.0 
ABBREVIATIONS AND TERMS .......................................................................................... 4 
3.0 
ETHICS..................................................................................................................................... 4 
4.0 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE ............................... 4 
5.0 
BACKGROUND/RATIONALE .............................................................................................. 4 
6.0 
STUDY OBJECTIVES ............................................................................................................. 5 
7.0 
STUDY PRODUCT.................................................................................................................. 5 
8.0 
STUDY DESIGN...................................................................................................................... 7 
9.0 
STUDY SUBJECTS ................................................................................................................. 7 
10.0 STUDY PROCEDURES .......................................................................................................... 8 
11.0 ADVERSE EVENTS .............................................................................................................. 10 
12.0 DATA MANAGEMENT........................................................................................................ 11 
13.0 STATISTICAL ANALYSIS .................................................................................................. 12 
14.0 FINAL REPORT .................................................................................................................... 13 
15.0 MONITORING ....................................................................................................................... 13 
16.0 AMENDMENT PROCEDURES............................................................................................ 13 
17.0 ATTACHMENTS ................................................................................................................... 13 
18.0 CITATIONS ........................................................................................................................... 13 
19.0 INVESTIGATOR SIGNATURE............................................................................................ 14 
 
 
 
 

 
 
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2.0 ABBREVIATIONS AND TERMS 
 AE – Adverse Event 
 
 – a medical device that holds a standard endotracheal tube 
during oral intubation 
 
 – a medical device that holds a standard 
endotracheal tube or one with integrated subglottic suction capability during oral 
intubation 
 CRF – Case Report Form 
 CRO – Contract Research Organization 
 EC – Ethics Committee 
 eCRF – Electronic Case Report Form 
 EDC – Electronic Data Capture; a method used for electronic documentation of study 
procedures and data. 
 ET Tube – Endotracheal Tube including the subglottic lumen and pilot line 
 HIPAA – Health Insurance Portability and Accountability Act; a US law designed 
to provide privacy standards to protect patients' medical records and other health 
information provided to health plans, doctors, hospitals and other health care providers. 
 ICH – International Conference on Harmonization 
 ICU – Intensive Care Unit 
 IFU – Instructions for Use 
 IRB – Institutional Review Board 
 LAR – Legally Authorized Representative – individual(s) who are legally authorized 
under state and federal law to consent to research participation on behalf of a 
designated person 
 PHI – Protected Health Information; any information about health status, provision 
of health care, or payment for health care that can be linked to a specific individual. 
3.0 ETHICS 
3.1 
The study and any amendments will be reviewed by an EC or IRB 
 
3.2 
The study will be conducted in accordance with the ethical principles that have their 
origins in the Declaration of Helsinki. 
 
4.0 INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
This is a multiple site prospective assessment of the study product in ICU settings. The 
study is comprised of each subject wearing one study product until the device either needs to 
be changed or is no longer required by the subject.   
5.0 BACKGROUND/RATIONALE 
Endotracheal intubation is the placement of a flexible tube into the trachea via the nose or 
mouth, primarily the mouth. The primary purpose of intubation is to establish and maintain 

 
 
Clinical Protocol: 5855-I 
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an open airway for the patient.  ET tube securement with a fastener is critical for 
management of a patient with an ET tube in the ICU settings.  
 
The current commercially available 
 provides a convenient way to hold an oral ET tube 
securely in place with an integrated tube protection sleeve.  The 
 protection sleeve is 
designed to accommodate the standard ET tube sized 5.0-10.0mm.  Multiple ET tubes with 
subglottic suction capabilities are on the market and the current AnchorFast products do not 
easily accommodate these tubes. With the advent and usage of these ET types in the ICUs, 
 
 device with tube protection sleeve 
has been designed to hold both the standard ET tube sized 5.0-9.0mm and ET tube with 
integrated subglottic suction capability sized 6.0-8.0mm.  
 
This study is designed to assess the acceptability and usability of the study product by 
clinicians caring for an orally intubated patient using an ET tube with integrated subglottic 
suction capability. 
6.0 STUDY OBJECTIVE 
6.1 Objective 
The objective of this study is to assess the acceptability and usability of the study product 
during use. 
7.0 STUDY PRODUCT 
7.1 
INVESTIGATIONAL DEVICES  
The United States Food and Drug Administration (FDA) classify endotracheal tube 
holders under regulation 21 CFR 868.5770.  As such, AFGS is categorized as a Class 
I device.  Health Canada classifies AFGS as a Class I device with the Preferred 
Name Code (PNC) of 73CBH.  Class I devices: (1) are not intended as implants and 
do not present a potential for serious risk to the health, safety, or welfare of a 
subject; (2) are not purported or represented to be for use in supporting or sustaining 
human life; (3) are not for a use of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of human health; 
or (4) do not otherwise present a potential for serious risk to the health, safety or 
welfare of a subject. By this definition the study devices are non-significant risk 
devices. 
 
This non-significant risk clinical study, including the Informed Consent, will be 
reviewed by the institution’s EC or IRB in accordance with Title 21 of the Code of 
Federal Regulations, Parts 50 and 56 and/or conformance to Health Canada 
Subsection 80(3) and Section 81 of the Medical Devices Regulations.   EC or IRB 
approval will be obtained prior to study initiation at all study sites, as applicable. 
 

 
 
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7.2 
IDENTITY OF PRODUCT(S), PACKAGING AND STORAGE, TEST 
METHODS, PROCEDURES FOR RELEASE  
The study materials are oral endotracheal tube fasteners with adhesive skin barriers, 
adjustable neckband, and an updated tube protection sleeve. The devices are 
manufactured by Hollister Incorporated under protocol number 
, and 
released under standard manufacturing controls.  
 
 
 
All study materials are assessed by Biomaterials Safety and found to be safe for their 
intended use as documented in 
 
 
 
Study product will be labeled: 
 
 
 
Expiration date and Lot numbers are displayed on the package of the study product 
and are based on manufacturing date of study product. 
 
The devices are supplied non-sterile and individually packaged.  All study materials 
are stored in a secure location at room temperature.  Extreme hot or cold 
temperatures should be avoided. 
 
7.3 
RESPONSIBILITY FOR PRODUCT CONTROL, RETURN AND DISPOSAL 
A 
 is maintained at the site.  Used study 
product is disposed of as normal sanitary waste. If a study product fails, the 
Investigator or designee returns the study product that failed to the Sponsor within  
 unless otherwise notified.  Unused study product is either 
returned to the Sponsor or destroyed by the site according to Sponsor’s instructions.  
 
Manufactured by Hollister Incorporated 
Libertyville, IL 60048 USA 
Protocol 5855-I 
Rx Only 
 
1 Unit 
            
 
 
 
CAUTION – Investigational Device 
Limited by Federal Law for Investigational Use Only  
Not for Sale  
Instrument de recherché  
Réservé uniquement à l’usage de chercheurs compétents 
 

 
 
Clinical Protocol: 5855-I 
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7.4 
INSTRUCTIONS FOR USE OF INVESTIGATIONAL PRODUCT 
Study product is applied by the Investigator or designee according to the 
 
8.0 STUDY DESIGN 
8.1 STUDY PERIOD 
This is a multiple site prospective assessment of the study product in ICU settings. The 
study is comprised of each subject wearing one study product until the study product 
either needs to be changed or is no longer required by the subject, per 
  Subjects who meet the inclusion and exclusion criteria may 
enroll into the study.   
9.0 STUDY SUBJECTS 
9.1 INCLUSION CRITERIA 
a) Is 18 years of age or older and require oral tracheal intubation with subglottic ET 
tube size 6.0-8.0mm. 
b) Requires the use of a bite block (ex. 
, B&B Medical, etc.) per the 
hospital’s standard of care 
c) Has intact skin on and around application site, including cheeks and lips 
d) Oral cavity is free of open sores, ulcers, wounds, and lesions 
e) Subject or LAR able to provide informed consent for the study 
f) Is qualified to participate in the opinion of the Investigator, or designee  
 
9.2 EXCLUSION CRITERIA 
a) Has actual or perceived loose teeth, is without teeth, or is unable to wear upper 
dentures. 
b) Has facial hair that interferes with the adhesion of the skin barrier pads 
c) Has a clinically significant skin disease or condition, or damaged skin on the 
application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, 
sunburns, scars, moles 
d) Has a medical condition, surgery or a procedure that prevents the proper application 
of the device, including placement of the neck strap.  
e) Has a known or stated allergy to adhesives 
f) Currently is participating in any clinical study which may affect the performance of 
the device 
 
9.3 SUBJECT TREATMENT AND CARE 
All subject care is consistent with standard health care practices. No treatment is 
withheld or altered during the course of the study.  
 
9.4 STUDY STOPPING RULES 
If 
 of enrolled subjects are discontinued due to reasons related to the study 
product, the Sponsor will assess if the study should be continued.  

 
 
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10.0 STUDY PROCEDURES 
10.1 
RECRUITMENT/SUBJECT IDENTIFICATION PROCEDURE 
Subjects who meet the stated inclusion and exclusion criteria are recruited by the 
Investigator or designee.  At least thirty (30) subjects are enrolled. 
 
Subjects are assigned an identification code by study personnel.  
  All data forms identify the subject by this identification only.  All study 
data is confidential and kept in a secure location.  The Subject ID is documented on 
 
 
10.2 
ENROLLMENT 
Enrollment follows Informed Consent (see Section 10.3) but both may occur during 
the same visit.  The Investigator, or designee confirms Inclusion and Exclusion 
Criteria (listed in Sections 9.1 and 9.2) prior to enrolling the subject. 
 
10.3 
INFORMED CONSENT 
Written informed consent is obtained from all qualified subjects or the subject’s 
LAR prior to enrolling in the study. Subjects or the subject’s LAR have the study 
explained to them by the Investigator or designee, read the Informed Consent form, 
have the opportunity to ask questions, and sign the approved Informed Consent form 
prior to any protocol procedures. The subject (or their LAR) is given a signed copy 
of the Informed Consent form. Written consent to use Personal Health Information 
(PHI) under HIPAA (USA) or according to Canadian regional Healthcare Privacy 
Laws is obtained. 
 
10.4 
BLINDING 
This is an open label study and there is no blinding. 
 
10.5 
PRIOR AND CONCOMITANT THERAPY 
Concomitant therapy is not relevant to this study and is not collected. 
 
10.6 
SUBJECT VISITS AND EVALUATION METHODS 
 

 
 
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10.7 
SUBJECT / CAREGIVER INSTRUCTIONS 
All subject care is consistent with standard health care practices.  No treatment is 
withheld or altered during the course of the study. The Investigator or designee uses 
the study product’s instructions for use 
 
 
10.8 
COMPLIANCE 
Site personnel and study subjects are expected to fully comply with the protocol and 
study procedures.  If the site personnel or subjects deviate from the protocol at any 
point, 
 is completed.  Sites are monitored for 
compliance.  If a site is found to have multiple deviations, corrective action or re-
training may be necessary. 

 
 
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10.9 
PROCEDURES FOR SUBJECT WITHDRAWAL 
Subjects or their LAR must be informed of their right to withdraw from participation 
in the study at any time without prejudice. The Investigator or designee may choose 
to discontinue a subject from the study. Reasons for subject discontinuation include, 
but are not limited to, the occurrence of an adverse event (see Section 11). If the 
subject withdraws from the study or is discontinued by the Investigator, 
 is completed.  
 
While being orally intubated, there is a possibility that the tongue could become 
swollen and/or displaced from its normal resting place and result in contact with the 
study product or prevent the study product from moving/shuttling properly.  If in the 
clinician’s assessment of the subject, the study product should be removed, complete 
a 
  The occurrence of tongue displacement is 
also captured on 
    
 
Any new information gained during the study that might affect the subject’s or 
subject’s LAR desire to continue their participation in the study is conveyed to them 
in a timely manner. 
 
10.10 INVESTIGATOR RESPONSIBILITIES 
It is the responsibility of the Investigator to follow applicable ICH Good Clinical 
Practice Guidelines and regulations including compliance with the protocol, 
recruiting and enrolling of appropriate subjects, properly storing and accounting for 
study product, ensuring adequate medical care is provided to subjects, properly 
obtaining Informed Consent, properly reporting Adverse Events, and maintaining all 
study related documents for a minimum of 2 years once informed from the Sponsor 
that the study is officially closed.  
 
10.11 SPONSOR RESPONSIBILITIES 
It is the responsibility of Hollister to oversee the overall conduct of the trial and 
verify study procedures are adhered to by the Investigator.  Hollister may transfer 
any or all trial-related duties and functions to a CRO, but the ultimate responsibility 
for the quality and integrity of the study data resides with the sponsor. (ICH GCP 
5.2.1) 
11.0 ADVERSE EVENTS 
Anticipated Adverse Events 
There is a small possibility that the subject may experience mild skin irritation.  This may 
occur with the repeated application and removal of any adhesive material currently available 
on the market and while noted in the study file is not considered an adverse event.   
 

 
 
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Unanticipated Adverse Events 
An unanticipated adverse event occurs when the nature, severity or frequency of the event is 
not consistent with the known or foreseeable risk of the anticipated adverse events 
associated with the study product or procedures involved with this research.   
 
Serious Adverse Events 
A serious adverse event is one that results in death, results in life-threatening illness or 
injury, requires in-patient hospitalization or prolongation of hospitalization, results in 
medical intervention to prevent permanent impairment, or results in permanent impairment 
of body structure or function, or that result in injury or death to a fetus.   There are no 
serious adverse related to the study product anticipated in this study.  
 
Handling of Adverse Events 
The Investigator or designee will determine if an adverse event has occurred and if it was 
related to the study product.  Adverse events are documented on 
 
 within the EDC system.  The Investigator or designee indicates if the adverse 
event is related to the study product by marking “possibly”, “probably”, or “definitely” on 
the Adverse Event Form.   
 
All Adverse Events are followed to determine resolution as prescribed by the hospital’s 
standard of care and the Adverse Event form is updated to indicate date of resolution.  If at 
any point, the Investigator or designee determines the subject should no longer use the study 
product, the subject should be discontinued from the study. 
 
Reporting of Adverse Events 
Unanticipated and serious adverse events related to the study product must be reported by 
the Investigator or designee through the EDC system within 24 hours by documenting on 
. 
 
Unanticipated or serious adverse events related to the study product must be promptly 
reported to the EC or IRB, per their reporting procedures. 
12.0 DATA MANAGEMENT 
It is the responsibility of the Investigator to ensure the completeness and accuracy of the 
Case Report Forms.  It is the responsibility of the Investigator and the monitor to resolve 
any data queries recorded in the CRFs.  All attachments are collected by the Sponsor except 
 
 
The Sponsor implements edit checks on the eCRF to enforce data entry guidelines, data 
consistency, and compliance to the protocol and regulatory requirements.  The Investigator 
or designee is responsible for entering study data into the EDC system.  The Sponsor tracks 
eCRFs and reviews them for completeness, the presence of mandatory values, consistency, 
and dated electronic signatures.  The Sponsor generates data clarification queries during the 
review process to ensure data quality.  Once the Investigator or designee have provided 

 
 
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acceptable responses to the queries and implemented the changes on the eCRFs, the Sponsor 
closes the queries with the appropriate resolution status.  At the end of the study, the 
database is locked and the data is released for reporting and statistical analysis. 
 
All required signatures on the eCRF are provided electronically by the Investigator or 
designee.  Access to the eCRF for data entry and signature is controlled by user 
identification and password, which are provided by the Sponsor or designee. Investigators 
and their personnel are trained, by Sponsor and/or a designated CRO, in the use of eCRFs 
and application of electronic signatures before the start of the study. 
 
Because it is extremely important to have proper data collection in a timely manner, the 
Investigator or designee and subjects complete the eCRFs on an ongoing basis.  It is 
expected that the eCRFs for a particular subject are reviewed and completed by the 
Investigator or designee within 
 hours of study product application and within 
 hours of 
study product removal.   
 
The Investigator or designee enters the data into the EDC system and retains the original 
source documents in the study binder for the monitor to perform source document 
verification as needed. The Investigator agrees to maintain all study files in a secure location 
for a minimum of two years. 
13.0 STATISTICAL ANALYSIS 
13.1 DATA ANALYSIS OF OBJECTIVE 
Study data will be presented in their entirety or summarized using simple descriptive 
statistics; any open comments obtained will be provided without analysis or 
interpretation.  No hypothesis tests, inferences to any population or any other statistical 
analyses are planned. 
 
 
 
The objective will be assessed via questionnaire items relating to product application, 
 and product removal. 
Overall acceptability relating to general experience with the study product will also be 
ascertained. 
 
13.2 SAMPLE SIZE AND POWER 
The sample size of 30 was chosen based on a literature review of two comparable sample 
size studies. Both studies aimed at comparing effectiveness of ET tube securement 
techniques.  In the first study, a power analysis was performed before patient enrollment that 
determined 17 patients would need to be enrolled to show a difference of one standard 
deviation from the mean between the two fixation techniques at 80% power and 5% type 1 
error. The sample size of 30 patients was chosen to increase the power of results and include 
a larger variety of patients undergoing different surgical procedures1. The second study, a 
randomized controlled study, included a sample of 90 patients with 30 in each arm to 

 
 
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compare the effectiveness of three ET tube securement techniques (Twill, Adhesive, and 
Simple Bow) with respect to ET tube slippage, external jugular pressure measurement, oral 
mucosa and facial integrity and patient satisfaction after the fixation method2. Details 
regarding the power, type 1 error, and effect size sought were not provided. 
14.0 FINAL REPORT 
The Sponsor is responsible for issuing a final report to the study sites.  It is the responsibility 
of the Investigator to provide a final report to the IRB/EC, as required. 
15.0 MONITORING 
A qualified Hollister Incorporated monitor or designee(s) monitor(s) the study. 
16.0 AMENDMENT PROCEDURES 
The sponsor is responsible for initiating any protocol amendments.  Approval of the 
amendment must be obtained by the IRB prior to implementation.  Investigator(s) are 
notified of the changes, and a copy of the amendment is kept in the study file.   
17.0 ATTACHMENTS 
 
 
 
 
 
 
 
 
 
 
18.0 CITATIONS 
1. Buckley, J.,Brown, A.,Shin, J., Rodgers, K. & Hoftman, N. (2016) A Comparison of the 
Haider Tube-Guard® Endotracheal Tube Holder Versus Adhesive Tape to Determine if 
This Novel Device Can reduce Endotracheal tube Movement and Prevent Unplanned 
Extubation. Anesthesia and Analgesia 122(5):1439-1443. 
2. Mohammed, H & Hassan, M. (2015). Endotracheal tube securements: Effectiveness of three 
techniques among orally intubated patients. Egyptian Journal of Chest Diseases and 
Tuberculosis 64:183-196 
 

 
 
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19.0 INVESTIGATOR SIGNATURE 
I have read the foregoing protocol and agree to conduct the study as outlined herein. 
 
Investigator’s Signature __________________________________ Date: ______________ 
 
Acknowledgement Signature 
for Hollister Incorporated _________________________________Date:_______________