Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation

Conditions
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Anesthesia Induction Ventilation

Intervention / Treatment
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* Device: Waters Mask
* Other: Standard Mask


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Waters Mask<br>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<br>* 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).<br>|
| Active Comparator: Standard Mask<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warters Scale Score | The primary outcome will be the Warters Scale score for each mask, compared between patients. | one year |