Respiratory Insufficiency
Conditions
Brief 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.
Detailed description
This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.
Interventions
OTHERExperimental ET Tube Securement Device
Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.
Sponsors
Hollister Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use | 14 days | Number of participants with damage of ET tube and Number of participants with occlusion of ET tube |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use | Between 1 - 14 days | Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy); |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited between July 2012 to February 2013 in the ICU setting at 6 hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Hollister ET Tube Securement Device Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | unable to apply product | 3 |
Baseline characteristics
| Characteristic | Hollister ET Tube Securement Device |
|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 15.6 |
| Reason for intubation Other | 5 participants |
| Reason for intubation Post-operative | 3 participants |
| Reason for intubation Respiratory Failure | 55 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 65 |
| serious Total, serious adverse events | 4 / 65 |
Outcome results
Primary
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
Number of participants with damage of ET tube and Number of participants with occlusion of ET tube
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hollister Endotracheal (ET) Tube Securement Device | Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use | Damage to ET tube | 0 participants |
| Hollister Endotracheal (ET) Tube Securement Device | Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use | Occlusion of ET Tube | 1 participants |
Secondary
Ease of Use
Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);
Time frame: Between 1 - 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hollister Endotracheal (ET) Tube Securement Device | Ease of Use | 63 % rating with score of 4 and 5 |