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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02760927

Enrollment

Registered

2016-05-04

Start date

2016-03-31

Completion date

2016-05-31

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Depression, Respiratory Failure, Ventilatory Depression

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.

Interventions

DEVICEEndotracheal 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve	Typical wear time of endotracheal tube fastener up to one week	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)
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses

Countries

United States

Participant flow

Participants by arm

Arm	Count
Endotracheal Tube Fastener The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube. 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.	4
Total	4

Arm

Count

Endotracheal Tube Fastener

The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube. 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Tube Slippage from Device	1

Baseline characteristics

Characteristic	Endotracheal Tube Fastener
Age, Continuous	47 years STANDARD_DEVIATION 18
Race/Ethnicity, Customized Race/Ethic Heritage Asian or Pacific Islander	1 Participants
Race/Ethnicity, Customized Race/Ethic Heritage White (not of Hispanic origin)	3 Participants
Region of Enrollment United States	4 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 4
other Total, other adverse events	2 / 4
serious Total, serious adverse events	0 / 4