Oxygen Consumption In Critically Ill Children

July 22, 2021 updated by: The Hospital for Sick Children

A Pilot Study of the Relationship Between Oxygen Delivery and Consumption During Extracorporeal Membrane Oxygenation.

The investigators propose to examine the relationship between DO2 and VO2 in critically ill patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can provide complete support of heart and lung function. In so doing, the investigators will be able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow through the ECMO circuit.

Null Hypothesis:

Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not associated with an increase in oxygen consumption.

Alternate Hypothesis:

Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is associated with an increase in oxygen consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V1X8
        • The Hospital for Sick Children

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

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in the Critical Care Unit on veno-arterial ECMO.
  • Hemodynamic stability established, as adjudged by the treating CCU staff physician.
  • Informed consent by parent or legal guardian.
  • Approval by treating CCU staff physician to approach parents/guardians for consent process at any given time.

Exclusion Criteria:

  • Patients in the Critical Care Unit on veno-venous (VV) ECMO.
  • Inability to tolerate study period without red cell transfusion.
  • Presence of a large leak around the endotracheal tube (> 10% tidal volume).
  • Patients requiring > 70 % FiO2 at the time of potential enrollment.
  • Parent or legal guardian refuse consent.

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

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients on veno-arterial (VA) ECMO
Device: Extracorporeal blood flow via ECMO machine

Extracorporeal Membrane Oxygenation (ECMO) machine can provide complete support of heart and lung function.

Extracorporeal blood flow will be given at baseline rate, increased by 25% and decreased by 25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen consumption (VO2)
Time Frame: Baseline
VO2 will be measured using a mass spectrometer as this is the gold standard.
Baseline
Oxygen consumption (VO2)
Time Frame: 30min
VO2 will be measured using a mass spectrometer as this is the gold standard.
30min
Oxygen consumption (VO2)
Time Frame: 60min
VO2 will be measured using a mass spectrometer as this is the gold standard.
60min
Oxygen consumption (VO2)
Time Frame: 90min
VO2 will be measured using a mass spectrometer as this is the gold standard.
90min

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial serum lactate level
Time Frame: Baseline, 30min, 60min, 90min
Baseline, 30min, 60min, 90min
Oxygen extraction ratio.
Time Frame: Baseline, 30min, 60min, 90min
Baseline, 30min, 60min, 90min

Collaborators and Investigators

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

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Brian Kavanagh, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (ESTIMATE)

January 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1000017147

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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