NuMask Versus Traditional Mask Ventilation During Routine Care

Derek Sakata

Status: Completed

Conditions: Apnea

Treatments: Device: NuMask; Device: Traditional mask

Study type: Observational

Funder types: Other

Identifiers

NCT02828280

IRB_00042299

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

NuMask

Description:

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

Treatment:

Device: Traditional mask

Device: NuMask

Traditional mask

Description:

patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask

Treatment:

Device: Traditional mask

Device: NuMask