Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

NCT ID: NCT01943227

Last Updated: 2019-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-03-31

Brief Summary

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This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy).

Detailed Description

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This is a single site, prospective, non-blinded, non-randomized, noninterventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy). Each patient will serve as their own control. The study will enroll adult patients without cardiac or respiratory illness. It is designed to evaluate the effect of the ventilatory pattern (tidal volume, rate) on respiratory heat loss measured using the VQm™ monitor during standard intra-operative clinical care that requires positive pressure ventilation (PPV)

Conditions

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Ventilation Perfusion Mismatch

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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6ml/kg

Enthalpy measured in patients receiving controlled positive pressure ventilation 6ml/kg Tidal volume.

The VQm monitor samples the gas at a rate of 3 L/min, returning the analyzed gas to the circuit. As the exhaled gas passes through the analytical chamber, the temperature and humidity are measured essentially continuously (40Hz). These data are combined with pressure measurements to determine the exhaled gas volume and then the heat content (enthalpy) is calculated.

controlled positive pressure ventilation 6ml/kg tidal volume

Intervention Type OTHER

controlled positive pressure ventilation 6ml/kg tidal volume

9ml/kg

Enthalpy measured in patients receiving controlled positive pressure ventilation 9ml/kg Tidal volume.

The VQm monitor samples the gas at a rate of 3 L/min, returning the analyzed gas to the circuit. As the exhaled gas passes through the analytical chamber, the temperature and humidity are measured essentially continuously (40Hz). These data are combined with pressure measurements to determine the exhaled gas volume and then the heat content (enthalpy) is calculated.

controlled positive pressure ventilation 9ml/kg tidal volume

Intervention Type OTHER

controlled positive pressure ventilation 9ml/kg tidal volume

Interventions

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controlled positive pressure ventilation 9ml/kg tidal volume

controlled positive pressure ventilation 9ml/kg tidal volume

Intervention Type OTHER

controlled positive pressure ventilation 6ml/kg tidal volume

controlled positive pressure ventilation 6ml/kg tidal volume

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age greater than 18 years
* scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia and positive pressure ventilation using an endotracheal tube
* patient status ASA 1, 2 or 3
* no significant cardio-vascular or respiratory disease
* supine surgical position

Exclusion Criteria

* Adults unable to give primary consent
* age less than 18 years
* pregnancy
* prisoners
* pre-existing cardiac or pulmonary disease
* infusion of inotropic drugs
* positive end expiratory pressure (PEEP) requirements \>8 cm H2O
* increased intra-abdominal pressure (e.g. planned surgical pneumoperitoneum or ascitis)
* intra-operative patient position other than supine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Fleming, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Anesthesiology & Pain Medicine

Locations

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UC Davis Health System

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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483184

Identifier Type: -

Identifier Source: org_study_id

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