N/A
Completed N=500
Endotracheal Tube Securement Study
Mechanical Ventilation Complication
Source: ClinicalTrials.gov NCT03760510 ↗
Enrolled (actual)
500
Serious AEs
1.3%
Results posted
Jul 2019
Primary outcomePrimary: 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; 22.0 events per 1000 ventilator days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
52.6; 22.0 | — |
| SECONDARY Number of Participants With Lip Ulcers |
11; 4 | — |
| SECONDARY Number of Participants With Facial Skin Tear |
3; 2 | — |
| SECONDARY Number of Participants With Ett Dislodgement |
15; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03760510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.