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Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content

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ClinicalTrials.gov Identifier: NCT02153164
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). This study would be carried out on patients whose operation requires the use of the steep Trendelenburg position independent of this study.

Condition or disease
Effect of Patient Position on Airway Heat Content

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
Actual Study Start Date : May 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2016



Primary Outcome Measures :
  1. Respired gas heat content [ Time Frame: 6 months ]
    (6 months for protocol and 2 hours per patient)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elective surgery requiring steep Trendelenberg position.
Criteria

Inclusion Criteria:

  • age greater than 18 years
  • scheduled for an elective surgical procedure requiring general anesthesia, positive pressure ventilation using an endotracheal tube and the steep Trendelenburg position

Exclusion Criteria:

  • Adults unable to give primary consent
  • age less than 18 years
  • pregnancy
  • prisoners
  • infusion of inotropic drugs
  • positive end expiratory pressure (PEEP) requirements >8 cm H2O Women, minorities or non-English speaking subjects will not be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153164


Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Neal W. Fleming, M.D., Ph.D. University of California Davis, Department of Anesthesiology and Pain Medicine

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02153164     History of Changes
Other Study ID Numbers: 589602
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Keywords provided by University of California, Davis:
Enthalpy
Trendelenberg position
Mechanical ventilation