Oxygen Consumption In Critically Ill Children

NCT ID: NCT01521195

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

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.

Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients on veno-arterial (VA) ECMO

Group Type EXPERIMENTAL

Extracorporeal blood flow via ECMO machine

Intervention Type 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%

Interventions

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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%

Intervention Type DEVICE

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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Kavanagh, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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 Med. 2015 Sep 15;192(6):765-7. doi: 10.1164/rccm.201502-0267LE. No abstract available.

Reference Type RESULT
PMID: 26371816 (View on PubMed)

Other Identifiers

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1000017147

Identifier Type: -

Identifier Source: org_study_id

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