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

Phase 1

Completed

• Conditions: Respiratory Complications Due to Anesthesia
• Interventions: Device: Noninvasive Ventilator, V60 (Philips); Device: Manual Bag

• Registration Number: NCT02623270
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-07
• Primary Completion: 2016-05
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Noninvasive Ventilation	Manual Bag	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)
Noninvasive Ventilation	Noninvasive Ventilator, V60 (Philips)	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)

Primary Outcome Measures

Name	Time	Method
Average of the difference in Respiratory Rate between Manual and Mechanical Ventilation (1/min)	Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation.	Difference in average respiratory rate between manual ventilation and mechanical noninvasive ventilation averaged per patient, then averaged across all studied patients. Unit: 1/min.
Average of the difference in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)	Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation	Difference in average tidal volume per ideal body weight between manual ventilation and mechanical noninvasive ventilation, averaged per patient, then averaged across all studied patients. Unit: mL/kg
In-Patient Average Difference of Standard Deviation in Respiratory Rate between Manual and Mechanical Ventilation (1/min)	Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation	Difference in standard deviation of respiratory rate between manual ventilation and mechanical noninvasive ventilation averaged per patient, then averaged across all studied patients. Unit: 1/min.
In-Patient Average Difference of Standard Deviation in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)	Assessment will be made during the procedure during 10 consecutive breaths (depending on the breath rate, for approximately 1 minute) after induction but before intubation	Difference in standard deviation of tidal volume per ideal body weight between manual ventilation and mechanical noninvasive ventilation, averaged per patient, then averaged across all studied patients. Unit: mL/kg

Secondary Outcome Measures

Name	Time	Method
Difficulty or ease of ventilation as perceived by anesthesia provider	Assessment will be made within one hour after the surgery has been completed.	NASA TLX Score after each patient