Clinical trial NCT04274686: Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
Official title: Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Ventilation
Keywords: Tegaderm bandage
Bag mask ventilation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Air Leakage During Bag-mask Ventilation
timeFrame: <5 minutes
Secondary outcomes:
measure: Resistance
timeFrame: <5 minutes
measure: Peak Inspiratory Pressure
timeFrame: <5 minutes
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Neal Gerstein, MD
role: PRINCIPAL_INVESTIGATOR
References: