Oxygen Consumption In Critically Ill Children

Not Applicable

Completed

• Conditions: Extracorporeal Membrane Oxygenation
• Interventions: Device: Extracorporeal blood flow via ECMO machine

• Registration Number: NCT01521195
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-30
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients on veno-arterial (VA) ECMO	Extracorporeal blood flow via ECMO machine	-

Primary Outcome Measures

Name	Time	Method
Oxygen consumption (VO2)	90min	VO2 will be measured using a mass spectrometer as this is the gold standard.

Secondary Outcome Measures

Name	Time	Method
Arterial serum lactate level	Baseline, 30min, 60min, 90min
Oxygen extraction ratio.	Baseline, 30min, 60min, 90min

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada