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Completed

NCT Number: NCT01943227

Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Health System

Sacramento, California, 95817, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

controlled positive pressure ventilation 9ml/kg tidal volume

Other

controlled positive pressure ventilation 9ml/kg tidal volume

controlled positive pressure ventilation 6ml/kg tidal volume

Other

controlled positive pressure ventilation 6ml/kg tidal volume

Primary outcomes

  1. Airway Enthalpy

    Time frame: 12 months

    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) in Joules per minute.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2013
Registry last updated
Oct 28, 2019

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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