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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Complications Due to Anesthesia
• Intervention / Treatment: Device: Noninvasive Ventilator, V60 (Philips); Device: Manual Bag

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Noninvasive Ventilation; 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)

Device: Noninvasive Ventilator, V60 (Philips); The noninvasive ventilator will be set to deliver 10 breaths per minute with a pressure setting of 8 cm H2O during exhalation and 20 cm H2O during inspiration. The inspired oxygen fraction given by the ventilator will be set at the maximum level (100% oxygen).; Device: Manual Bag; Oxygen will flow through the standard breathing circuit with the fresh gas flow rate set at 10 L/min and the patient will be ventilated. The anesthesia provider will manually bag mask ventilate the patient until the anesthesiologist feels comfortable that the patient can be ventilated appropriately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average of the difference in Respiratory Rate between Manual and Mechanical Ventilation (1/min)	Difference in average respiratory rate between manual ventilation and mechanical noninvasive ventilation averaged per patient, then averaged across all studied patients. Unit: 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.
Average of the difference in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)	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	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
In-Patient Average Difference of Standard Deviation in Respiratory Rate between Manual and Mechanical Ventilation (1/min)	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.	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
In-Patient Average Difference of Standard Deviation in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)	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	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Aeronautics and Space Administration (NASA)

Publications and helpful links

General Publications

• Fogarty M, Orr JA, Sakata D, Brewer L, Johnson K, Fang JC, Kuck K. A comparison of ventilation with a non-invasive ventilator versus standard O2 with a nasal cannula for colonoscopy with moderate sedation using propofol. J Clin Monit Comput. 2020 Dec;34(6):1215-1221. doi: 10.1007/s10877-019-00426-5. Epub 2019 Nov 23.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (ESTIMATE): December 7, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00080301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data.