Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

NCT ID: NCT04274686

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2021-05-03

Brief Summary

Difficult Bag Mask Ventilation is well described in the anesthesiology literature, and bearded patients are likely to experience this phenomenon. This study involves application of a large and perforated Tegaderm® across the lower face of the bearded patient to quantify its effectiveness at improving mask ventilation in this anesthetized population.

Detailed Description

This study is a prospective crossover trial in bearded patients who will undergo elective or urgent surgery at the main operating rooms of the University of New Mexico Hospital.

It is planned to test the efficacy of the novel bag mask ventilation augmentation technique of placing a large perforated Tegaderm® over the mouth of bearded male patients in order to improve seal after induction of general anesthesia. The perforation is a diamond-shaped hole to be aligned with the patient's mouth. Patients will either start with Tegaderm application or without Tegaderm, and will then cross over to the other condition in order to be their own controls. The primary endpoint is to measure inspiratory and expiratory tidal volumes.

If shown efficacious this intervention would be an easy and cost-effective intervention to improve bag mask ventilation for bearded patients in the operating room and non-operating room environments alike.

Conditions

Pulmonary Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bag-Mask Ventilation with Tegaderm

Patients will receive bag-mask ventilation with Tegaderm placement

Group Type: EXPERIMENTAL

Tegaderm placement

Intervention Type: DEVICE

Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation

Bag-Mask Ventilation without Tegaderm

Patients will receive bag-mask ventilation without Tegaderm placement

Group Type: ACTIVE_COMPARATOR

No Tegaderm

Intervention Type: OTHER

Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage

Interventions

Tegaderm placement

Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation

Intervention Type: DEVICE

No Tegaderm

Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients with perioral facial hair >5mm in length
• Undergoing elective non-cardiac surgery with planned bag-mask ventilation during anesthesia induction

Exclusion Criteria

• Known allergy to Tegaderm product and/or its adhesive
• Emergency surgery
• Active or unstable cardiac disease
• ASA (American Society of Anesthesiologists) physical status ≥4
• External or internal active airway obstruction from tumor, abscess, or laryngeal edema
• Organic or non-organic oropharyngeal anatomical defects including history of radiation treatment to the neck
• Moderate to severe acute and chronic restrictive or obstructive lung diseases, e.g. chronic obstructive pulmonary disease, asthma, etc.
• Requirement for rapid sequence intubation, or known aspiration risk
• Cervical spine injury
• Previously documented difficult mask ventilation or intubation
• BMI ≥50
• Vulnerable populations: children, prisoners, pregnant patients, cognitively impaired adults

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Neal Gerstein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Gerstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico Hospital

Albuquerque, New Mexico, United States

Countries

United States

References

Gerstein NS, Braude DA, Petersen TR, Goumas A, Fish AC, Panikkath PV. Use of Transparent Film Dressing to Facilitate Mask Ventilation in Bearded Patients. J Emerg Med. 2024 Feb;66(2):163-169. doi: 10.1016/j.jemermed.2023.07.008. Epub 2023 Jul 20.

Reference Type: DERIVED

PMID: 38238230 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UNMBMVbeard

Identifier Type: -

Identifier Source: org_study_id