An interventional study of New oral endotracheal tube holder in Intubation, sponsored by Hollister Incorporated. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Hollister Incorporated · Not applicable, Interventional, and Other
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
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.
Hollister Incorporated is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Study Product Arm
Device: New oral endotracheal tube holder
The single arm study product is designed to hold a standard or subglottic ET tube.
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)
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)
| Milestone | New Oral Endotracheal Tube Holder |
|---|---|
| Started | 34 |
| Completed | 30 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 2 |
| Withdrew: No product evaluated | 1 |
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
| Participants | New Oral Endotracheal Tube Holder |
|---|---|
| Very Acceptable | 13 |
| Acceptable | 15 |
| Neither acceptable nor acceptable | 0 |
| Unacceptable | 2 |
| Very Unacceptable | 0 |
The usability of the study product at application and at removal.
| Participants | New Oral Endotracheal Tube Holder |
|---|---|
| Ease of application — Very easy to apply | 20 |
| Ease of application — Easy to apply | 8 |
| Ease of application — Neither easy nor difficult to apply | 1 |
| Ease of application — Difficult to apply | 1 |
| Ease of application — Very difficult to apply | 0 |
| Ease of application — Not Applicable | 0 |
| Ease of removal — Very easy to apply | 18 |
| Ease of removal — Easy to apply | 7 |
| Ease of removal — Neither easy nor difficult to apply | 2 |
| Ease of removal — Difficult to apply | 1 |
| Ease of removal — Very difficult to apply | 0 |
| Ease of removal — Not Applicable | 2 |
Collected over maximum 29 days of patient wearing product. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| New Oral Endotracheal Tube Holder | 1/30 (3.3%) | 3/30 (10%) | 1/30 (3.3%) |
| Event | New Oral Endotracheal Tube Holder |
|---|---|
| DeathInfections and infestations | 1/30 |
| Oral BleedingGeneral disorders | 1/30 |
| Loose teethGeneral disorders | 1/30 |
| Event | New Oral Endotracheal Tube Holder |
|---|---|
| Skin lesionSkin and subcutaneous tissue disorders | 1/30 |
Enrolled patients found eligible per Inclusion/Exclusion Criteria
| Age, Continuous(years) | New Oral Endotracheal Tube Holder |
|---|---|
| Mean | 52.5 (21 to 84) |
| Sex: Female, Male(Participants) | New Oral Endotracheal Tube Holder |
|---|---|
| Female | 13 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | New Oral Endotracheal Tube Holder |
|---|
| Region of Enrollment(participants) | New Oral Endotracheal Tube Holder |
|---|---|
| United States | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Hollister Incorporated