A Comparison of Controlled Ventilation With the V60 Non-Invasive Ventilator vs. Traditional Mask Ventilation

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 1

Conditions: Respiratory Complications Due to Anesthesia

Treatments: Device: Noninvasive Ventilator, V60 (Philips); Device: Manual Bag

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02623270

IRB_00080301

Details and patient eligibility

About

The purpose of this study is to determine whether an experienced anesthesia provider can adequately and/or easily mask ventilate an anesthetized patient with a commercial non-invasive ventilator device.

Full description

The purpose of this study is to determine whether an experienced anesthesia provider can adequately and/or easily mask ventilate an anesthetized patient with a commercial non-invasive ventilator device. The ventilator subject of this study is commonly used in the ICU and investigators aim to evaluate its usefulness in the OR. Investigators believe that the ventilator will ventilate with consistent breath rates, adequate tidal volumes and minimal airway pressures. The providers subjective scoring of ease or difficulty of ventilation with each device will also be recorded.

Enrollment: 20 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults between 18-74 years of age,
• ASA status I-III,
• presenting for elective surgery requiring general anesthesia at the University of Utah
• able and will to provide informed consent

Exclusion criteria

• 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,
• restrictive lung disease,
• personal or familial history of malignant hyperthermia
• known or predicted severe respiratory disease or compromise.
• Female subjects must have a negative urine pregnancy screen.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Noninvasive Ventilation

Experimental group

Description:

After induction of anesthesia, checking of ability to bag mask ventilating the patient, the manual bag ventilation will be replaced by a Noninvasive Ventilator, V60 (Philips)

Treatment:

Device: Noninvasive Ventilator, V60 (Philips)

Device: Manual Bag