Clinical trial NCT02623270: A Comparison of Controlled Ventilation With the V60 Non-Invasive Ventilator vs. Traditional Mask Ventilation
Official title: A Comparison of Controlled Ventilation With the V60 Non-Invasive Ventilator vs. Traditional Mask Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Complications Due to Anesthesia
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Aeronautics and Space Administration (NASA)
First posted: 2015-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Average of the difference in Respiratory Rate between Manual and Mechanical Ventilation (1/min)
timeFrame: 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.
measure: Average of the difference in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)
timeFrame: 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
measure: In-Patient Average Difference of Standard Deviation in Respiratory Rate between Manual and Mechanical Ventilation (1/min)
timeFrame: 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
measure: In-Patient Average Difference of Standard Deviation in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)
timeFrame: 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:
measure: Difficulty or ease of ventilation as perceived by anesthesia provider
timeFrame: Assessment will be made within one hour after the surgery has been completed.
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Kai Kuck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.