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Completed

NCT Number: NCT01521195

Oxygen Consumption In Critically Ill Children

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.

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Key information

Conditions

Extracorporeal Membrane Oxygenation

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal blood flow via ECMO machine

Device

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%

Primary outcomes

  1. Oxygen consumption (VO2)

    Time frame: Baseline

    VO2 will be measured using a mass spectrometer as this is the gold standard.

  2. Oxygen consumption (VO2)

    Time frame: 30min

    VO2 will be measured using a mass spectrometer as this is the gold standard.

  3. Oxygen consumption (VO2)

    Time frame: 60min

    VO2 will be measured using a mass spectrometer as this is the gold standard.

  4. Oxygen consumption (VO2)

    Time frame: 90min

    VO2 will be measured using a mass spectrometer as this is the gold standard.

Secondary outcomes

  1. Arterial serum lactate level

    Time frame: Baseline, 30min, 60min, 90min

  2. Oxygen extraction ratio.

    Time frame: Baseline, 30min, 60min, 90min

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 30, 2012
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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