ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of an Endotracheal Tube Securement Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01651260
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : October 28, 2015
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Respiratory Insufficiency
Intervention Other: Experimental ET Tube Securement Device
Enrollment 65
Recruitment Details Subjects were recruited between July 2012 to February 2013 in the ICU setting at 6 hospitals.
Pre-assignment Details  
Arm/Group Title Hollister ET Tube Securement Device
Hide Arm/Group Description Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
Period Title: Overall Study
Started 65
Completed 62
Not Completed 3
Reason Not Completed
unable to apply product             3
Arm/Group Title Hollister ET Tube Securement Device
Hide Arm/Group Description Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
Complete demographic profiles were obtained for 63 participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants
57.8  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
28
  44.4%
Male
35
  55.6%
Reason for intubation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants
Respiratory Failure 55
Post-operative 3
Other 5
1.Primary Outcome
Title Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
Hide Description Number of participants with damage of ET tube and Number of participants with occlusion of ET tube
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hollister Endotracheal (ET) Tube Securement Device
Hide Arm/Group Description:
Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: participants
Damage to ET tube 0
Occlusion of ET Tube 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hollister Endotracheal (ET) Tube Securement Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter upper probability of failure
Estimated Value .05
Estimation Comments Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.
2.Secondary Outcome
Title Ease of Use
Hide Description Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);
Time Frame Between 1 - 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hollister ET Tube Securement Device
Hide Arm/Group Description:
Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: % rating with score of 4 and 5
63
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hollister ET Tube Securement Device
Hide Arm/Group Description Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
All-Cause Mortality
Hollister ET Tube Securement Device
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hollister ET Tube Securement Device
Affected / at Risk (%) # Events
Total   4/65 (6.15%)    
General disorders   
Loosened teeth * [1]  1/65 (1.54%)  1
Death * [2]  1/65 (1.54%)  1
Death * [3]  1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders   
Obstruction of ET tube * [4]  1/65 (1.54%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Three upper teeth loose. Probably related to device.
[2]
Patient on terminal wean expired with device in place. Unrelated to device.
[3]
Patient on terminal wean expired with device in place. Unrelated to device
[4]
Blood oxygen saturation (SpO2) dropped from 100% to 60% due to patient biting ET tube. Unrelated to the device.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hollister ET Tube Securement Device
Affected / at Risk (%) # Events
Total   4/65 (6.15%)    
Skin and subcutaneous tissue disorders   
Ulcer on tongue * [1]  1/1 (100.00%)  1
Upper lip breakdown * [2]  1/1 (100.00%)  1
Wound on upper palette * [3]  1/1 (100.00%)  1
Bleeding tongue. * [4]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Ulcer on tongue possibly related to device.
[2]
Upper lip ulcer probably related to device.
[3]
Wound on upper palette probably related to device.
[4]
Patient forced tongue to opposite side of jaw and bit the tongue. Unrelated to the device.
Adult subjects in respiratory insufficiency in ICU setting were intubated with only four ET tube sizes: 7.0, 7.5, 8.0 and 8.5 mm. No other sizes were represented in the sample population.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Malford Cullum
Organization: Hollister Incorporated
Phone: 847-918-3975
Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01651260     History of Changes
Other Study ID Numbers: 5156-I
First Submitted: July 16, 2012
First Posted: July 27, 2012
Results First Submitted: March 18, 2014
Results First Posted: October 28, 2015
Last Update Posted: March 23, 2016