Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Ventilation

Intervention / Treatment
-----------------
* Device: Tegaderm placement
* Other: No Tegaderm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bag-Mask Ventilation with Tegaderm<br>Patients will receive bag-mask ventilation with Tegaderm placement | Device: Tegaderm placement<br>* Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation<br>|
| Active Comparator: Bag-Mask Ventilation without Tegaderm<br>Patients will receive bag-mask ventilation without Tegaderm placement | Other: No Tegaderm<br>* Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tegaderm bandage, Bag mask ventilation