Intubation
Conditions
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.
Interventions
DEVICENew oral endotracheal tube holder
The single arm study product is designed to hold a standard or subglottic ET tube.
Sponsors
Hollister Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm 2. Requires the use of a bite block per the hospital's standard of care 3. Has intact skin on and around application site, including cheeks and lips 4. Oral cavity is free of open sores, ulcers, wounds, and lesions 5. Subject or Legal Authorized representative (LAR) able to provide informed consent for the study 6. Is qualified to participate in the opinion of the Investigator, or designee
Exclusion criteria
1. Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures 2. Has facial hair that interferes with the adhesion of the skin barrier pads 3. Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles 4. Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap. 5. Has a known or stated allergy to adhesives 6. Currently is participating in any clinical study which may affect the performance of the device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Oral Endotracheal Tube Holder Single Study Product Arm
New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Product Evaluated | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | New Oral Endotracheal Tube Holder | — |
|---|---|---|
| Age, Continuous | 52.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 3 / 30 |
Outcome results
Primary
Overall Acceptability With Study 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
Time frame: At product removal (maximum 29 days of patient wearing product)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Oral Endotracheal Tube Holder | Overall Acceptability With Study Product | Very Acceptable | 13 Participants |
| New Oral Endotracheal Tube Holder | Overall Acceptability With Study Product | Acceptable | 15 Participants |
| New Oral Endotracheal Tube Holder | Overall Acceptability With Study Product | Neither acceptable nor acceptable | 0 Participants |
| New Oral Endotracheal Tube Holder | Overall Acceptability With Study Product | Unacceptable | 2 Participants |
| New Oral Endotracheal Tube Holder | Overall Acceptability With Study Product | Very Unacceptable | 0 Participants |
Primary
Usability of Study Product
The usability of the study product at application and at removal.
Time frame: At application and product removal (maximum 29 days of patient wearing product)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of application | Very easy to apply | 20 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of application | Easy to apply | 8 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of application | Neither easy nor difficult to apply | 1 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of application | Difficult to apply | 1 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of application | Very difficult to apply | 0 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of application | Not Applicable | 0 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of removal | Very easy to apply | 18 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of removal | Easy to apply | 7 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of removal | Neither easy nor difficult to apply | 2 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of removal | Difficult to apply | 1 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of removal | Very difficult to apply | 0 Participants |
| New Oral Endotracheal Tube Holder | Usability of Study Product | Ease of removal | Not Applicable | 2 Participants |