Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content

August 10, 2017 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elective surgery requiring steep Trendelenberg position.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respired gas heat content
Time Frame: 6 months
(6 months for protocol and 2 hours per patient)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 589602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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