N/A
Completed N=65
Assessment of an Endotracheal Tube Securement Device
Respiratory Insufficiency
Source: ClinicalTrials.gov NCT01651260 ↗
Enrolled (actual)
65
Serious AEs
6.2%
Results posted
Oct 2015
Primary outcomePrimary: Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use — 0; 1 participants
Summary
Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use |
0; 1 | — |
| SECONDARY Ease of Use |
63 | — |
Eligibility Criteria
Inclusion Criteria
- Is 18 years of age or older; male or female and requiring oral tracheal intubation.
- Has intact skin on application site.
- Willingly signs or their authorized representative willingly signs the Informed Consent.
- Is qualified to participate in the opinion of the Investigator.
Exclusion Criteria
- Has an existing neck injury.
- Has protruding upper teeth, without teeth or is unable to wear upper dentures.
- Has facial hair.
- Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
- Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
- Has a known or stated allergy to adhesive bandages, or any of the product types being tested.
- Uses of topical drugs on the application site.
- Uses lotions, creams or oils on the application site.
- Currently is participating in any clinical testing which may affect performance of this device.
- Has been previously intubated with skin irritation or pressure sores surrounding the mouth.
Data sourced from ClinicalTrials.gov (NCT01651260). 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.