NuMask Versus Traditional Mask Ventilation During Routine Care

Study Overview
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Brief Summary
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The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.

Official Title
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A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.

Conditions
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Apnea

Intervention / Treatment
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* Device: NuMask
* Device: Traditional mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 44 adults total ASA status I-III aged 18-64 elective surgery at the University of Utah under general anesthesia Bearded, BMI >35 or edentulous Exclusion Criteria: ASA IV or higher Oropharyngeal or facial pathology Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease) Known and/or documented difficulty placing an endotracheal tube in the past Limited neck extension or flexion Personal or familial history of malignant hyperthermia Known or predicted severe respiratory disease or compromise Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NuMask<br>Pt's randomized to Numask first will be ventilated for 10 breaths with the NuMask device first, followed by 10 breaths with the traditional face mask | Device: NuMask<br>* The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.<br>Device: Traditional mask<br>* A traditional air inflated facemark used to ventilate patients<br>|
| Traditional mask<br>patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask | Device: NuMask<br>* The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.<br>Device: Traditional mask<br>* A traditional air inflated facemark used to ventilate patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tidal Volume comparison | Tidal volumes delivered between the two devices will be compared | 2 minutes (one minute for NuMask, one minute for traditional mask) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Provider will rate each device for ease of use on a 1-5 scale with 1 being easy and 5 being difficult. | 2 minutes |