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Completed

NCT Number: NCT02623270

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.

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Key information

Conditions

Respiratory Complications Due to Anesthesia

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Average of the difference in Respiratory Rate between Manual and Mechanical Ventilation (1/min)

    Time frame: 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.

  2. Average of the difference in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)

    Time frame: 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

  3. In-Patient Average Difference of Standard Deviation in Respiratory Rate between Manual and Mechanical Ventilation (1/min)

    Time frame: 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.

  4. In-Patient Average Difference of Standard Deviation in ideal body weight indexed tidal volume between Manual and Mechanical Ventilation (mL/kg)

    Time frame: 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 outcomes

  1. Difficulty or ease of ventilation as perceived by anesthesia provider

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

    NASA TLX Score after each patient

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2015
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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