Clinical trial NCT02760927: Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes
Official title: Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Depression
Respiratory Failure
Ventilatory Depression
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction

Detailed description: Endotracheal intubation is the trans laryngeal placement of a tube into the trachea via the nose or mouth. Subglottic suctioning, during endotracheal tube securement, is important for mechanically-ventilated patients to allow for the clearance of secretions that may accumulate during intubation. This protocol examines an enhancement to the current AnchorFast Guard device in order for the device to hold a subglottic suctioning lumen in addition to the intubation tube.

Eligibility criteria: Inclusion Criteria:

* Is 18 years of age or older and requires oral tracheal intubation
* Has intact skin on application site
* Is qualified to participate in the opinion of the Investigator including the requirement for endotracheal tube with subglottic suction

Exclusion Criteria:

* Has an existing neck injury
* Has protruding upper teeth, is without teeth or is unable to wear upper dentures
* Has facial hair
* Has clinically significant skin damage, condition or disease on the application site which may contraindicate participation
* Has a known or stated allergy to adhesive bandages, or any of the product types being tested
* Uses of topical drugs, lotions, creams or oils on the application site
* Is participating in any clinical testing which may affect performance of this device
* AnchorFast Guard Oral Endotracheal Tube Fastener does not fit subject's face

Primary outcomes:
measure: Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
timeFrame: Typical wear time of endotracheal tube fastener up to one week
measure: Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
timeFrame: Typical wear time of endotracheal tube fastener up to one week
measure: Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
timeFrame: Typical wear time of endotracheal tube fastener up to one week
measure: Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
timeFrame: Typical wear time of endotracheal tube fastener up to one week
measure: Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
timeFrame: Typical wear time of endotracheal tube fastener up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Gresham
country: United States
facility: Legacy Mt Hood
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan
state: Oregon
city: Vancouver
country: United States
facility: Legacy Salmon Creek Medical Center
state: Washington
Study officials:
affiliation: Legacy Research Institute IRB
name: Paul Newton, JD
role: STUDY_CHAIR
References: