Oxygen Consumption In Critically Ill Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01521195

Enrollment

Registered

2012-01-30

Start date

2011-10-31

Completion date

2014-02-28

Last updated

2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation

Keywords

pediatric, ECMO, extracorporeal blood flow, VO2

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.

Interventions

DEVICEExtracorporeal 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%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Oxygen consumption (VO2)	Baseline	VO2 will be measured using a mass spectrometer as this is the gold standard.

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026