Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

Overview

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.

Full Title of Study: “Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2021

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.

Interventions

  • 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
  • Other: No Tegaderm
    • Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage

Arms, Groups and Cohorts

  • Experimental: Tegaderm application
    • Patients will receive bag-mask ventilation with Tegaderm placement.
  • Active Comparator: No Tegaderm
    • Patients will receive bag-mask ventilation without Tegaderm placement.

Clinical Trial Outcome Measures

Primary Measures

  • Ventilation air leakage
    • Time Frame: <5 minutes
    • Difference between inspired tidal volume and expired tidal volume

Secondary Measures

  • Peak inspiratory pressure
    • Time Frame: <5 minutes
    • Air pressure measurement
  • Airway resistance
    • Time Frame: <5 minutes
    • Measurement of resistance to air flow

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of New Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Neal Gerstein, Professor – University of New Mexico
  • Overall Official(s)
    • Neal Gerstein, MD, Principal Investigator, University of New Mexico
  • Overall Contact(s)
    • Neal Gerstein, MD, 5052722610, ngerstein@salud.unm.edu

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