Trial Outcomes & Findings for Endotracheal Tube Securement Study (NCT NCT03760510)
NCT ID: NCT03760510
Last Updated: 2019-07-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
48 hours post extubation up to 3 months
Results posted on
2019-07-10
Participant Flow
Participant milestones
| Measure |
Adhesive Tape
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
COMPLETED
|
145
|
153
|
|
Overall Study
NOT COMPLETED
|
105
|
97
|
Reasons for withdrawal
| Measure |
Adhesive Tape
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
Overall Study
Not ventilated for 24 hours
|
105
|
97
|
Baseline Characteristics
Endotracheal Tube Securement Study
Baseline characteristics by cohort
| Measure |
Adhesive Tape
n=145 Participants
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
n=153 Participants
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 16.1 • n=39 Participants
|
53.2 years
STANDARD_DEVIATION 16.4 • n=41 Participants
|
55.8 years
STANDARD_DEVIATION 16.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=39 Participants
|
76 Participants
n=41 Participants
|
142 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=39 Participants
|
77 Participants
n=41 Participants
|
156 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=39 Participants
|
122 Participants
n=41 Participants
|
233 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
APACHE II
|
27.4 units on a scale
STANDARD_DEVIATION 8.7 • n=39 Participants
|
26.0 units on a scale
STANDARD_DEVIATION 8.9 • n=41 Participants
|
26.7 units on a scale
STANDARD_DEVIATION 8.8 • n=35 Participants
|
PRIMARY outcome
Timeframe: 48 hours post extubation up to 3 monthsPopulation: Enrolled patients ventilated for at least 24 hours who had primary outcome data
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
Outcome measures
| Measure |
Adhesive Tape
n=145 Participants
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
n=153 Participants
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
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
|
52.6 events per 1000 ventilator days
Interval 47.4 to 57.8
|
22.0 events per 1000 ventilator days
Interval 16.3 to 27.7
|
SECONDARY outcome
Timeframe: 48 hours post extubation up to 3 monthsPopulation: Enrolled patients mechanically ventilated for at least 24 hours
Presence of lip ulcer
Outcome measures
| Measure |
Adhesive Tape
n=145 Participants
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
n=153 Participants
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
Number of Participants With Lip Ulcers
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 48 hours post extubation up to 3 monthsPopulation: Enrolled participants receiving mechanical ventilation for at least 24 hours
presence of facial skin tear
Outcome measures
| Measure |
Adhesive Tape
n=145 Participants
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
n=153 Participants
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
Number of Participants With Facial Skin Tear
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: duration of intubation up to 3 monthsPopulation: Enrolled participants receiving mechanical ventilation for at least 24 hours
frequency of ett dislodgement
Outcome measures
| Measure |
Adhesive Tape
n=145 Participants
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
n=153 Participants
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
Number of Participants With Ett Dislodgement
|
15 Participants
|
6 Participants
|
Adverse Events
Adhesive Tape
Serious events: 2 serious events
Other events: 0 other events
Deaths: 54 deaths
Tube Fastener
Serious events: 2 serious events
Other events: 0 other events
Deaths: 57 deaths
Serious adverse events
| Measure |
Adhesive Tape
n=145 participants at risk
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape.
|
Tube Fastener
n=153 participants at risk
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Self-Extubation
|
1.4%
2/145 • Number of events 2 • Until 48 hours after extubation
Adverse events were collected prospectively and included self-extubations.
|
1.3%
2/153 • Number of events 2 • Until 48 hours after extubation
Adverse events were collected prospectively and included self-extubations.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place