MedTrace Logo

Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

NCT03158207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2017-05-18

No results posted yet for this study

Summary

Positive pressure ventilation can be life saving for patients who are hypoxic, hypercapneic or apneic. Manual ventilation with a facemask is a skill that is routinely required for emergency medical technicians, respiratory therapists, nurses and physicians. Although mask ventilation skills are routinely taught, even the most skilled and experienced anesthesiologists struggle to effectively mask-ventilate.

The effective use of a standard mask requires the simultaneous establishment of a seal between the mask and face and the lifting of the jaw. The preferred grip is referred to as the C\&E technique. The C\&E technique requires the index finger and thumb to form a "C" and push down on the mask to establish a seal between the mask and face. The lateral three fingers form the "E" and wrap under the jaw to provide lift. The grip required to establish the seal and jaw lift simultaneously is awkward and difficult to teach. The basic design of the standard facemask has not changed in approximately 100 years.

This study will evaluate a new mask design, Warters Mask, is based on a novel design that allows a far more ergonomic grip. The C\&E technique is replaced by a more natural grip. With the Warters Mask, downward pressure with the palm of the hand centered on the mask provides the seal between the face and the mask. The other four fingers align under the jaw to provide lift.

Conditions

  • Anesthesia Induction Ventilation

Interventions

DEVICE

Waters Mask

All anesthesiologists and CRNAs will view an instructional video on the use of the Warters Mask. Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).

OTHER

Standard Mask

Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales). Mask ventilation will be scored with both masks before and after the standard administration of paralytic medication.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Tod Brown, MD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2016-12-15
Completion
2016-12-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03158207 on ClinicalTrials.gov