Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Ventilation
• Intervention / Treatment: Device: Tegaderm placement; Other: No Tegaderm

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bag-Mask Ventilation with Tegaderm; Patients will receive bag-mask ventilation with Tegaderm placement	Device: 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
ACTIVE_COMPARATOR: Bag-Mask Ventilation without Tegaderm; Patients will receive bag-mask ventilation without Tegaderm placement	Other: No Tegaderm; Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Air Leakage During Bag-mask Ventilation	Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.	<5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance	Airflow resistance during bag-mask ventilation	<5 minutes
Peak Inspiratory Pressure	Maximum air pressure observed during bag-mask ventilation	<5 minutes

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2020
• Primary Completion (ACTUAL): May 3, 2021
• Study Completion (ACTUAL): May 3, 2021

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (ACTUAL): February 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Tegaderm bandage; Bag mask ventilation
• Other Study ID Numbers: UNMBMVbeard

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No