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

NCT02623270 | Completed Phase 1

• 1 other identifier: IRB_00080301
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Complications Due to Anesthesia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Difficulty or ease of ventilation as perceived by anesthesia provider

  Assessment will be made within one hour after the surgery has been completed.

Study Arms (1)

Noninvasive Ventilation

EXPERIMENTAL

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); Device: Manual Bag

Interventions

Noninvasive Ventilator, V60 (Philips) DEVICE

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).

Noninvasive Ventilation

Manual Bag DEVICE

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.

Noninvasive Ventilation

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Aeronautics and Space Administration (NASA): collaborator

Related Publications (1)

• 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.

  PMID: 31760586 DERIVED

Study Officials

• Kai Kuck, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Bioengineering, Dept. of Anesthesiology

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: December 7, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share