Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

Not Applicable

Completed

• Conditions: Anesthesia Induction Ventilation
• Interventions: Device: Waters Mask; Other: Standard Mask

• Registration Number: NCT03158207
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09-15
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Status Verified: 2017-05
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-18
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Waters Mask	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.
Standard Mask	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.

Primary Outcome Measures

Name	Time	Method
Warters Scale Score	one year	The primary outcome will be the Warters Scale score for each mask, compared between patients.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States