Clinical trial NCT03158207: Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation
Official title: Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Induction Ventilation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Warters Scale Score
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Assistant Professor
name: Tod Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: