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

NCT ID: NCT02623270

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-08-31

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.

Conditions

Respiratory Complications Due to Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Noninvasive Ventilator, V60 (Philips)

Intervention Type: 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).

Manual Bag

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Aeronautics and Space Administration (NASA)

FED

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kai Kuck

Director of Bioengineering, Dept. of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Kuck, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

References

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.

Reference Type: DERIVED

PMID: 31760586 (View on PubMed)

Other Identifiers

IRB_00080301

Identifier Type: -

Identifier Source: org_study_id