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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhesive Tape | Experimental | Patients in adhesive tape arm had endotracheal tube secured with adhesive tape |
|
| Tube Fastener | Experimental | Patients in the tube fastener arm had endotrachel tube secured with tube fastener |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tube Fastener | Device | Endotrachel tube secured with tube fastener |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours post extubation up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lip Ulcers | Presence of lip ulcer | 48 hours post extubation up to 3 months |
| Number of Participants With Facial Skin Tear | presence of facial skin tear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janna Landsperger, ACNP | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31064406 | Derived | Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7. |
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publication in a peer-reviewed medical journal
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| ID | Title | Description |
|---|---|---|
| FG000 | Adhesive Tape | Patients in adhesive tape arm had endotracheal tube secured with adhesive tape Adhesive Tape: Endotracheal tube secured with adhesive tape. |
| FG001 | Tube Fastener | Patients in the tube fastener arm had endotrachel tube secured with tube fastener Tube Fastener: Endotrachel tube secured with tube fastener |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible patients had to be intubated for at least 24 hours.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adhesive Tape | Patients in adhesive tape arm had endotracheal tube secured with adhesive tape Adhesive Tape: Endotracheal tube secured with adhesive tape. |
| BG001 | Tube Fastener |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Enrolled patients ventilated for at least 24 hours who had primary outcome data | Posted | Mean | 95% Confidence Interval | events per 1000 ventilator days | 48 hours post extubation up to 3 months |
|
Until 48 hours after extubation
Adverse events were collected prospectively and included self-extubations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adhesive Tape | Patients in adhesive tape arm had endotracheal tube secured with adhesive tape Adhesive Tape: Endotracheal tube secured with adhesive tape. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-Extubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient self-extubation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janna Landsperger | Vanderbilt University Medical Center | 6153223412 | janna.landsperger@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2018 | Jun 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053832 | Surgical Tape |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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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.
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| Adhesive Tape | Device | Endotracheal tube secured with adhesive tape. |
|
| 48 hours post extubation up to 3 months |
| Number of Participants With Ett Dislodgement | frequency of ett dislodgement | duration of intubation up to 3 months |
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Tube Fastener: Endotrachel tube secured with tube fastener
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| APACHE II | Severity of Illness Score. Scores range from minimum value of 0 to maximum value of 71 points. Higher score indicates greater severity of illness. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Tube Fastener |
Patients in the tube fastener arm had endotrachel tube secured with tube fastener Tube Fastener: Endotrachel tube secured with tube fastener |
|
|
| Secondary | Number of Participants With Lip Ulcers | Presence of lip ulcer | Enrolled patients mechanically ventilated for at least 24 hours | Posted | Count of Participants | Participants | 48 hours post extubation up to 3 months |
|
|
|
| Secondary | Number of Participants With Facial Skin Tear | presence of facial skin tear | Enrolled participants receiving mechanical ventilation for at least 24 hours | Posted | Count of Participants | Participants | 48 hours post extubation up to 3 months |
|
|
|
| Secondary | Number of Participants With Ett Dislodgement | frequency of ett dislodgement | Enrolled participants receiving mechanical ventilation for at least 24 hours | Posted | Count of Participants | Participants | duration of intubation up to 3 months |
|
|
|
| 54 |
| 145 |
| 2 |
| 145 |
| 0 |
| 145 |
| EG001 | Tube Fastener | Patients in the tube fastener arm had endotrachel tube secured with tube fastener Tube Fastener: Endotrachel tube secured with tube fastener | 57 | 153 | 2 | 153 | 0 | 153 |
|
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