NCT04274686

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 21, 2022

Completed
Last Updated

September 21, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

February 14, 2020

Results QC Date

May 26, 2022

Last Update Submit

August 24, 2022

Conditions

Pulmonary Ventilation

Keywords

Tegaderm bandageBag mask ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Resistance

    <5 minutes

  • Peak Inspiratory Pressure

    <5 minutes

Study Arms (2)

Bag-Mask Ventilation with Tegaderm

EXPERIMENTAL

Patients will receive bag-mask ventilation with Tegaderm placement

Device: Tegaderm placement

Bag-Mask Ventilation without Tegaderm

ACTIVE COMPARATOR

Patients will receive bag-mask ventilation without Tegaderm placement

Other: No Tegaderm

Interventions

Tegaderm placementDEVICE

Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation

Bag-Mask Ventilation with Tegaderm
No TegadermOTHER

Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage

Bag-Mask Ventilation without Tegaderm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with perioral facial hair \>5mm in length
  • Undergoing elective non-cardiac surgery with planned bag-mask ventilation during anesthesia induction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

  • Gerstein NS, Braude DA, Petersen TR, Goumas A, Fish AC, Panikkath PV. Use of Transparent Film Dressing to Facilitate Mask Ventilation in Bearded Patients. J Emerg Med. 2024 Feb;66(2):163-169. doi: 10.1016/j.jemermed.2023.07.008. Epub 2023 Jul 20.

    PMID: 38238230DERIVED

Results Point of Contact

Title
Dr. Neal Gerstein
Organization
University of New Mexico
ngerstein@salud.unm.edu
505-272-2610

Study Officials

  • Neal Gerstein, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 18, 2020

Study Start

February 12, 2020

Primary Completion

May 3, 2021

Study Completion

May 3, 2021

Last Updated

September 21, 2022

Results First Posted

September 21, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)