Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

Pulmonary Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04274686
• Other study ID #: UNMBMVbeard
• Status: Terminated
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: May 3, 2021

Study information

• Verified date: August 2022
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Ventilation

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resistance	Airflow resistance during bag-mask ventilation	<5 minutes
Secondary	Peak Inspiratory Pressure	Maximum air pressure observed during bag-mask ventilation	<5 minutes