Trial Outcomes & Findings for Assessment of an Endotracheal Tube Securement Device (NCT NCT01651260)

NCT ID: NCT01651260

Last Updated: 2016-03-23

Results Overview

Number of participants with damage of ET tube and Number of participants with occlusion of ET tube

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2016-03-23

Participant Flow

Subjects were recruited between July 2012 to February 2013 in the ICU setting at 6 hospitals.

Participant milestones

Measure	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.
Overall Study STARTED	65
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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.
Overall Study unable to apply product	3

Baseline Characteristics

Assessment of an Endotracheal Tube Securement Device

Baseline characteristics by cohort

Measure	Hollister ET Tube Securement Device n=63 Participants 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.
Age, Continuous	57.8 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Reason for intubation Respiratory Failure	55 participants n=5 Participants
Reason for intubation Post-operative	3 participants n=5 Participants
Reason for intubation Other	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Number of participants with damage of ET tube and Number of participants with occlusion of ET tube

Outcome measures

Measure	Hollister Endotracheal (ET) Tube Securement Device n=62 Participants 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.
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use Damage to ET tube	0 participants
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use Occlusion of ET Tube	1 participants

SECONDARY outcome

Timeframe: 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);

Outcome measures

Measure	Hollister Endotracheal (ET) Tube Securement Device n=62 Participants 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.
Ease of Use	63 % rating with score of 4 and 5

Adverse Events

Hollister ET Tube Securement Device

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hollister ET Tube Securement Device n=65 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Obstruction of ET tube	1.5% 1/65 • Number of events 1
General disorders Loosened teeth	1.5% 1/65 • Number of events 1
General disorders Death	1.5% 1/65 • Number of events 1

Other adverse events

Measure	Hollister ET Tube Securement Device n=65 participants at risk 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.
Skin and subcutaneous tissue disorders Ulcer on tongue	100.0% 1/1 • Number of events 1
Skin and subcutaneous tissue disorders Upper lip breakdown	100.0% 1/1 • Number of events 1
Skin and subcutaneous tissue disorders Wound on upper palette	100.0% 1/1 • Number of events 1
Skin and subcutaneous tissue disorders Bleeding tongue.	100.0% 1/1 • Number of events 1

Additional Information

Malford Cullum

Hollister Incorporated

Phone: 847-918-3975

Email: malford.cullum@Hollister.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60