Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes

Respiratory Failure Clinical Trial

Official title:

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02760927
• Other study ID #: 5799-I
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: August 2018
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Respiratory Depression
• Respiratory Failure
• Respiratory Insufficiency
• Ventilatory Depression

Intervention

Device:
• Endotracheal Tube Fastener
The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.

Locations

Country	Name	City	State
United States	Legacy Mt Hood	Gresham	Oregon
United States	Legacy Good Samaritan	Portland	Oregon
United States	Legacy Salmon Creek Medical Center	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen	Assessed by the proportion of yes/no researcher responses	Typical wear time of endotracheal tube fastener up to one week
Primary	Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve	Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)	Typical wear time of endotracheal tube fastener up to one week
Primary	Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract	Assessed by the proportion of yes/no researcher responses	Typical wear time of endotracheal tube fastener up to one week
Primary	Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen	Assessed by the proportion of yes/no researcher responses	Typical wear time of endotracheal tube fastener up to one week
Primary	Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning	Assessed by the proportion of yes/no researcher responses	Typical wear time of endotracheal tube fastener up to one week