Trial Outcomes & Findings for Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient (NCT NCT04274686)

NCT ID: NCT04274686

Last Updated: 2022-09-21

Results Overview

Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: <5 minutes
• Results posted on: 2022-09-21

Participant Flow

Participant milestones

Measure	Tegaderm-First Group Patients will first receive bag-mask ventilation with a perforated Tegaderm sheet in place, and then with the sheet removed	Without-Tegaderm First Group Patients will first receive bag-mask ventilation as in usual practice without a Tegaderm sheet in place, and then will receive bag-mask ventilation with a perforated Tegaderm sheet covering the lower face and beard
Overall Study STARTED	13	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Tegaderm-First Group Patients will first receive bag-mask ventilation with a perforated Tegaderm sheet in place, and then with the sheet removed	Without-Tegaderm First Group Patients will first receive bag-mask ventilation as in usual practice without a Tegaderm sheet in place, and then will receive bag-mask ventilation with a perforated Tegaderm sheet covering the lower face and beard
Overall Study Physician Decision	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=25 Participants All participants in the study
Age, Continuous	59 years STANDARD_DEVIATION 15 • n=25 Participants
Sex: Female, Male Female	1 Participants n=25 Participants
Sex: Female, Male Male	24 Participants n=25 Participants
Region of Enrollment United States	25 participants n=25 Participants
Beard Length 5 mm	8 Participants n=25 Participants
Beard Length 5-9 mm	3 Participants n=25 Participants
Beard Length 1 cm	6 Participants n=25 Participants
Beard Length >1 cm	8 Participants n=25 Participants

PRIMARY outcome

Timeframe: <5 minutes

Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.

Outcome measures

Measure	Bag-mask Ventilation With Tegaderm Placement n=24 Participants Bag-mask ventilation in study condition with perforated Tegaderm sheet placed over lower face and beard	Bag-mask Ventilation Without Tegaderm Placement n=24 Participants Bag-mask ventilation in control condition with mask placed directly over face and beard, as in usual practice, with no Tegaderm sheet
Percent Air Leakage During Bag-mask Ventilation	47.6 percentage of inspired tidal volume Standard Deviation 26.2	45.7 percentage of inspired tidal volume Standard Deviation 20.4

SECONDARY outcome

Timeframe: <5 minutes

Airflow resistance during bag-mask ventilation

Outcome measures

Measure	Bag-mask Ventilation With Tegaderm Placement n=24 Participants Bag-mask ventilation in study condition with perforated Tegaderm sheet placed over lower face and beard	Bag-mask Ventilation Without Tegaderm Placement n=24 Participants Bag-mask ventilation in control condition with mask placed directly over face and beard, as in usual practice, with no Tegaderm sheet
Resistance	8.83 cm H2O/L/s Standard Deviation 5.57	7.73 cm H2O/L/s Standard Deviation 3.69

SECONDARY outcome

Timeframe: <5 minutes

Maximum air pressure observed during bag-mask ventilation

Outcome measures

Measure	Bag-mask Ventilation With Tegaderm Placement n=24 Participants Bag-mask ventilation in study condition with perforated Tegaderm sheet placed over lower face and beard	Bag-mask Ventilation Without Tegaderm Placement n=24 Participants Bag-mask ventilation in control condition with mask placed directly over face and beard, as in usual practice, with no Tegaderm sheet
Peak Inspiratory Pressure	19.3 cm H2O Standard Deviation 1.6	19.4 cm H2O Standard Deviation 1.3

Adverse Events

Bag-mask Ventilation With Tegaderm Placement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bag-mask Ventilation Without Tegaderm Placement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Neal Gerstein

University of New Mexico

Phone: 505-272-2610

Email: ngerstein@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place