NCT04274686

Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Ventilation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-12
• Primary completion: 2021-05-03
• Completion: 2021-05-03
• First posted: 2020-02-18
• Last updated: 2022-09-21
• Results posted: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study