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Endotracheal Tube Securement Study (ETTS)

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ClinicalTrials.gov Identifier: NCT03760510
Recruitment Status : Completed
First Posted : November 30, 2018
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Mechanical Ventilation Complication
Interventions Device: Tube Fastener
Device: Adhesive Tape
Enrollment 500
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adhesive Tape Tube Fastener
Hide Arm/Group Description

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

Period Title: Overall Study
Started 250 250
Completed 145 153
Not Completed 105 97
Reason Not Completed
Not ventilated for 24 hours             105             97
Arm/Group Title Adhesive Tape Tube Fastener Total
Hide Arm/Group Description

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

Total of all reporting groups
Overall Number of Baseline Participants 145 153 298
Hide Baseline Analysis Population Description
Eligible patients had to be intubated for at least 24 hours.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 153 participants 298 participants
58.5  (16.1) 53.2  (16.4) 55.8  (16.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 153 participants 298 participants
Female
66
  45.5%
76
  49.7%
142
  47.7%
Male
79
  54.5%
77
  50.3%
156
  52.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 153 participants 298 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
23
  15.9%
19
  12.4%
42
  14.1%
White
111
  76.6%
122
  79.7%
233
  78.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   7.6%
12
   7.8%
23
   7.7%
APACHE II   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 153 participants 298 participants
27.4  (8.7) 26.0  (8.9) 26.7  (8.8)
[1]
Measure Description: Severity of Illness Score. Scores range from minimum value of 0 to maximum value of 71 points. Higher score indicates greater severity of illness.
1.Primary Outcome
Title Rate of Any Incidence of the Following: 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
Hide Description Rate per 1000 ventilator days of any incidence of the following: 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
Time Frame 48 hours post extubation up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients ventilated for at least 24 hours who had primary outcome data
Arm/Group Title Adhesive Tape Tube Fastener
Hide Arm/Group Description:

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

Overall Number of Participants Analyzed 145 153
Mean (95% Confidence Interval)
Unit of Measure: events per 1000 ventilator days
52.6
(47.4 to 57.8)
22.0
(16.3 to 27.7)
2.Secondary Outcome
Title Number of Participants With Lip Ulcers
Hide Description Presence of lip ulcer
Time Frame 48 hours post extubation up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients mechanically ventilated for at least 24 hours
Arm/Group Title Adhesive Tape Tube Fastener
Hide Arm/Group Description:

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

Overall Number of Participants Analyzed 145 153
Measure Type: Count of Participants
Unit of Measure: Participants
11
   7.6%
4
   2.6%
3.Secondary Outcome
Title Number of Participants With Facial Skin Tear
Hide Description presence of facial skin tear
Time Frame 48 hours post extubation up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants receiving mechanical ventilation for at least 24 hours
Arm/Group Title Adhesive Tape Tube Fastener
Hide Arm/Group Description:

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

Overall Number of Participants Analyzed 145 153
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.1%
2
   1.3%
4.Secondary Outcome
Title Number of Participants With Ett Dislodgement
Hide Description frequency of ett dislodgement
Time Frame duration of intubation up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants receiving mechanical ventilation for at least 24 hours
Arm/Group Title Adhesive Tape Tube Fastener
Hide Arm/Group Description:

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

Overall Number of Participants Analyzed 145 153
Measure Type: Count of Participants
Unit of Measure: Participants
15
  10.3%
6
   3.9%
Time Frame Until 48 hours after extubation
Adverse Event Reporting Description Adverse events were collected prospectively and included self-extubations.
 
Arm/Group Title Adhesive Tape Tube Fastener
Hide Arm/Group Description

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Adhesive Tape: Endotracheal tube secured with adhesive tape.

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Tube Fastener: Endotrachel tube secured with tube fastener

All-Cause Mortality
Adhesive Tape Tube Fastener
Affected / at Risk (%) Affected / at Risk (%)
Total   54/145 (37.24%)      57/153 (37.25%)    
Show Serious Adverse Events Hide Serious Adverse Events
Adhesive Tape Tube Fastener
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/145 (1.38%)      2/153 (1.31%)    
Respiratory, thoracic and mediastinal disorders     
Self-Extubation * [1]  2/145 (1.38%)  2 2/153 (1.31%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Patient self-extubation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adhesive Tape Tube Fastener
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/145 (0.00%)      0/153 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Janna Landsperger
Organization: Vanderbilt University Medical Center
Phone: 6153223412
EMail: janna.landsperger@vumc.org
Layout table for additonal information
Responsible Party: Todd Rice, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03760510     History of Changes
Other Study ID Numbers: IRB #170596
First Submitted: November 26, 2018
First Posted: November 30, 2018
Results First Submitted: June 19, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019