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Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

Not Applicable
Terminated
Conditions
Pulmonary Ventilation
Interventions
Device: Tegaderm placement
Other: No Tegaderm
Registration Number
NCT04274686
Lead Sponsor
University of New Mexico
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
25
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Bag-Mask Ventilation with TegadermTegaderm placementPatients will receive bag-mask ventilation with Tegaderm placement
Bag-Mask Ventilation without TegadermNo TegadermPatients will receive bag-mask ventilation without Tegaderm placement
Primary Outcome Measures
NameTimeMethod
Percent Air Leakage During Bag-mask Ventilation<5 minutes

Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.

Secondary Outcome Measures
NameTimeMethod
Resistance<5 minutes

Airflow resistance during bag-mask ventilation

Peak Inspiratory Pressure<5 minutes

Maximum air pressure observed during bag-mask ventilation

Trial Locations

Locations (1)

University of New Mexico Hospital

🇺🇸

Albuquerque, New Mexico, United States

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