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

Effect of Patient Position on Airway Heat Content

Study Type

Observational

Enrollment (Actual)

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

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