Oxygen Consumption In Critically Ill Children

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521195
• Other study ID #: 1000017147
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: July 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation

Intervention

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%

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Tosoni A, La Rotta G, Breatnach C, Anand V, Foreman C, Davidson L, Redington AN, Kavanagh BP. Oxygen Delivery and Consumption Are Independent: Evidence from Venoarterial Extracorporeal Membrane Oxygenation in Resuscitated Children. Am J Respir Crit Care M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption (VO2)	VO2 will be measured using a mass spectrometer as this is the gold standard.	Baseline
Primary	Oxygen consumption (VO2)	VO2 will be measured using a mass spectrometer as this is the gold standard.	30min
Primary	Oxygen consumption (VO2)	VO2 will be measured using a mass spectrometer as this is the gold standard.	60min
Primary	Oxygen consumption (VO2)	VO2 will be measured using a mass spectrometer as this is the gold standard.	90min
Secondary	Arterial serum lactate level		Baseline, 30min, 60min, 90min
Secondary	Oxygen extraction ratio.		Baseline, 30min, 60min, 90min