Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

NCT ID: NCT03158207

Last Updated: 2017-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-15
• Study Completion Date: 2016-12-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).Mask ventilation will be scored before and after the standard administration of paralytic medication.

Group Type: EXPERIMENTAL

Waters Mask

Intervention Type: DEVICE

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).

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 before and after the standard administration of paralytic medication.

Group Type: ACTIVE_COMPARATOR

Standard Mask

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >18 years.
• Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.

Exclusion Criteria

• Need for awake intubation based on standard preoperative evaluation by the attending anesthesiologist.
• Increased risk for aspiration of gastric contents due to full stomach, pregnancy, gastro-esophageal reflux disease, and/or hiatal hernia as identified during the pre-operative assessment.
• Previous tracheostomy procedure.
• Patient is cognitively incapable of providing their consent for the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Tod A. Brown

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tod Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00047645

Identifier Type: -

Identifier Source: org_study_id