Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

NCT03158207 | Completed DMC

• 1 other identifier: Pro00047645
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Warters Scale Score

  The primary outcome will be the Warters Scale score for each mask, compared between patients.

  one year

Study Arms (2)

Waters Mask

EXPERIMENTAL

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.

Device: Waters Mask

Standard Mask

ACTIVE COMPARATOR

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.

Other: Standard Mask

Interventions

Waters Mask 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).

Waters Mask

Standard Mask 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.

Standard Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Tod Brown, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The sequence of standard vs Warters mask will be determined by random number generator. Mask ventilation will be scored with both masks before and after the standard administration of paralytic medication. After grading mask ventilation the study intervention is complete and the remainder of surgical and anesthesia care will be based on the clinical needs and decisions of the care team.

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: September 15, 2015
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

US (1)