Mechanical Ventilation Complication
Conditions
Keywords
endotracheal tube, tube fastener, facial skin tear, lip ulcer, endotracheal tube dislodgement
Brief summary
To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic, randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube fastener on complications including lip ulcers, facial skin tears, endotracheal tube dislodgement, and ventilator associated pneumonia among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
Detailed description
Background: The optimal securement method of endotracheal tubes is unknown, but should provide adequate security while minimizing complications. This study tests the hypothesis that use of an endotracheal tube fastener would reduce complications among critically ill adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic, single center, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
Interventions
DEVICETube Fastener
Endotrachel tube secured with tube fastener
DEVICEAdhesive Tape
Endotracheal tube secured with adhesive tape.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient intubated prior to admission to the MICU and the intubation time was less than 12 hours from the time of admission * Patients intubated in the MICU for greater than 24 hours
Exclusion criteria
* intubated greater than 12 hours prior to admission to the MICU * presence of oral mucosa or facial skin breakdown prior to enrollment * required nasotracheal intubation, * had a documented allergy to tape * pregnant * prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 48 hours post extubation up to 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Lip Ulcers | 48 hours post extubation up to 3 months | Presence of lip ulcer |
| Number of Participants With Facial Skin Tear | 48 hours post extubation up to 3 months | presence of facial skin tear |
| Number of Participants With Ett Dislodgement | duration of intubation up to 3 months | frequency of ett dislodgement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adhesive Tape Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Adhesive Tape: Endotracheal tube secured with adhesive tape. | 145 |
| Tube Fastener Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener | 153 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not ventilated for 24 hours | 105 | 97 |
Baseline characteristics
| Characteristic | Adhesive Tape | Tube Fastener | Total |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 16.1 | 53.2 years STANDARD_DEVIATION 16.4 | 55.8 years STANDARD_DEVIATION 16.3 |
| APACHE II | 27.4 units on a scale STANDARD_DEVIATION 8.7 | 26.0 units on a scale STANDARD_DEVIATION 8.9 | 26.7 units on a scale STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 19 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) White | 111 Participants | 122 Participants | 233 Participants |
| Sex: Female, Male Female | 66 Participants | 76 Participants | 142 Participants |
| Sex: Female, Male Male | 79 Participants | 77 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 54 / 145 | 57 / 153 |
| other Total, other adverse events | 0 / 145 | 0 / 153 |
| serious Total, serious adverse events | 2 / 145 | 2 / 153 |
Outcome results
Primary
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
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
Population: Enrolled patients ventilated for at least 24 hours who had primary outcome data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adhesive Tape | 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 |
| 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 | 22.0 events per 1000 ventilator days |
Secondary
Number of Participants With Ett Dislodgement
frequency of ett dislodgement
Time frame: duration of intubation up to 3 months
Population: Enrolled participants receiving mechanical ventilation for at least 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adhesive Tape | Number of Participants With Ett Dislodgement | 15 Participants |
| Tube Fastener | Number of Participants With Ett Dislodgement | 6 Participants |
Secondary
Number of Participants With Facial Skin Tear
presence of facial skin tear
Time frame: 48 hours post extubation up to 3 months
Population: Enrolled participants receiving mechanical ventilation for at least 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adhesive Tape | Number of Participants With Facial Skin Tear | 3 Participants |
| Tube Fastener | Number of Participants With Facial Skin Tear | 2 Participants |
Secondary
Number of Participants With Lip Ulcers
Presence of lip ulcer
Time frame: 48 hours post extubation up to 3 months
Population: Enrolled patients mechanically ventilated for at least 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adhesive Tape | Number of Participants With Lip Ulcers | 11 Participants |
| Tube Fastener | Number of Participants With Lip Ulcers | 4 Participants |