Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intubation
- Sponsor
- Hollister Incorporated
- Enrollment
- 34
- Locations
- 4
- Primary Endpoint
- Usability of Study Product
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
Detailed Description
This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Usability of Study Product
Time Frame: At application and product removal (maximum 29 days of patient wearing product)
The usability of the study product at application and at removal.
Overall Acceptability With Study Product
Time Frame: At product removal (maximum 29 days of patient wearing product)
The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable