Trial Outcomes & Findings for Assessment of an Oral Endotracheal Subglottic Tube Holder (NCT NCT03328182)

NCT ID: NCT03328182

Last Updated: 2019-07-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: At product removal (maximum 29 days of patient wearing product)
• Results posted on: 2019-07-05

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	2
Overall Study No Product Evaluated	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	New Oral Endotracheal Tube Holder n=30 Participants Single Study Product Arm New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.
Age, Continuous	52.5 years n=30 Participants
Sex: Female, Male Female	13 Participants n=30 Participants
Sex: Female, Male Male	17 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	New Oral Endotracheal Tube Holder n=30 Participants Single Study Product Arm 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 Very Acceptable	13 Participants
Overall Acceptability With Study Product Acceptable	15 Participants
Overall Acceptability With Study Product Neither acceptable nor acceptable	0 Participants
Overall Acceptability With Study Product Unacceptable	2 Participants
Overall Acceptability With Study Product Very Unacceptable	0 Participants

PRIMARY outcome

Timeframe: At application and product removal (maximum 29 days of patient wearing product)

The usability of the study product at application and at removal.

Outcome measures

Measure	New Oral Endotracheal Tube Holder n=30 Participants Single Study Product Arm New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.
Usability of Study Product Ease of removal · Not Applicable	2 Participants
Usability of Study Product Ease of application · Very easy to apply	20 Participants
Usability of Study Product Ease of application · Easy to apply	8 Participants
Usability of Study Product Ease of application · Neither easy nor difficult to apply	1 Participants
Usability of Study Product Ease of application · Difficult to apply	1 Participants
Usability of Study Product Ease of application · Very difficult to apply	0 Participants
Usability of Study Product Ease of application · Not Applicable	0 Participants
Usability of Study Product Ease of removal · Very easy to apply	18 Participants
Usability of Study Product Ease of removal · Easy to apply	7 Participants
Usability of Study Product Ease of removal · Neither easy nor difficult to apply	2 Participants
Usability of Study Product Ease of removal · Difficult to apply	1 Participants
Usability of Study Product Ease of removal · Very difficult to apply	0 Participants

Adverse Events

New Oral Endotracheal Tube Holder

Serious events: 3 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	New Oral Endotracheal Tube Holder n=30 participants at risk Single Study Product Arm New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.
Infections and infestations Death	3.3% 1/30 • Number of events 1 • maximum 29 days of patient wearing product Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.
General disorders Oral Bleeding	3.3% 1/30 • Number of events 1 • maximum 29 days of patient wearing product Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.
General disorders Loose teeth	3.3% 1/30 • Number of events 1 • maximum 29 days of patient wearing product Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.

Other adverse events

Measure	New Oral Endotracheal Tube Holder n=30 participants at risk Single Study Product Arm New oral endotracheal tube holder: The single arm study product is designed to hold a standard or subglottic ET tube.
Skin and subcutaneous tissue disorders Skin lesion	3.3% 1/30 • Number of events 1 • maximum 29 days of patient wearing product Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.

Additional Information

Director Global Clinical Affairs

Hollister Incorporated

Phone: 8476802837

Email: stacy.haddad@hollister.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 18 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER