Oxygen Consumption In Critically Ill Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Extracorporeal Membrane Oxygenation

Intervention / Treatment
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* Device: Extracorporeal blood flow via ECMO machine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients on veno-arterial (VA) ECMO<br> | Device: Extracorporeal blood flow via ECMO machine<br>* 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%<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, ECMO, extracorporeal blood flow, VO2