Assessment of an Oral Endotracheal Subglottic Tube Holder
- Conditions
- Intubation
- Interventions
- Device: New oral endotracheal tube holder
- Registration Number
- NCT03328182
- Lead Sponsor
- Hollister Incorporated
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description New oral endotracheal tube holder New oral endotracheal tube holder Single Study Product Arm
- Primary Outcome Measures
Name Time Method Usability of Study Product 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Legacy Emanuel Hospital & Health Center
🇺🇸Portland, Oregon, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Legacy Good Samaritan Medical Center
🇺🇸Portland, Oregon, United States
Community Regional Medical Center
🇺🇸Fresno, California, United States