Extracorporeal Membrane OxygenationNCT01521195
Oxygen Consumption In Critically Ill Children
A study testing Extracorporeal blood flow via ECMO machine in people with Extracorporeal Membrane Oxygenation, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- Extracorporeal blood flow via ECMO machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Relationship Between Oxygen Delivery and Consumption During Extracorporeal Membrane Oxygenation.
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:
Read more
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.
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- Extracorporeal blood flow via ECMO machine
- Keywords
- pediatric, ECMO, extracorporeal blood flow, VO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal blood flow via ECMO machineDevice
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 group | Role | What they receive |
|---|---|---|
| Patients on veno-arterial (VA) ECMO | Experimental | Not described Receives: Device: Extracorporeal blood flow via ECMO machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption (VO2)
VO2 will be measured using a mass spectrometer as this is the gold standard.
Measured: Baseline
Oxygen consumption (VO2)
VO2 will be measured using a mass spectrometer as this is the gold standard.
Measured: 30min
Oxygen consumption (VO2)
VO2 will be measured using a mass spectrometer as this is the gold standard.
Measured: 60min
Oxygen consumption (VO2)
VO2 will be measured using a mass spectrometer as this is the gold standard.
Measured: 90min
Secondary outcomes (2)
Arterial serum lactate level
Measured: Baseline, 30min, 60min, 90min
Oxygen extraction ratio.
Measured: Baseline, 30min, 60min, 90min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Kavanagh, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521195
- Sponsor's protocol ID
- 1000017147
- Status last verified
- Jul 2021
- First submitted
- 18 Jan 2012
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26371816
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Relationship Between Oxygen Delivery and Consumption During Extracorporeal Membrane Oxygenation.
- ClinicalTrials.gov ID
- NCT01521195
- Acronym / sponsor ID
- 1000017147
- Conditions
- Extracorporeal Membrane Oxygenation
- Keywords
- pediatric, ECMO, extracorporeal blood flow, VO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on veno-arterial (VA) ECMO | Experimental | Device: Extracorporeal blood flow via ECMO machine |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal blood flow via ECMO machineExtracorporeal 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% | Device | Patients on veno-arterial (VA) ECMO |
Primary outcome
Oxygen consumption (VO2)
Time frame: Baseline
VO2 will be measured using a mass spectrometer as this is the gold standard.
Oxygen consumption (VO2)
Time frame: 30min
VO2 will be measured using a mass spectrometer as this is the gold standard.
Oxygen consumption (VO2)
Time frame: 60min
VO2 will be measured using a mass spectrometer as this is the gold standard.
Oxygen consumption (VO2)
Time frame: 90min
VO2 will be measured using a mass spectrometer as this is the gold standard.
2 secondary outcomes
Arterial serum lactate level
Time frame: Baseline, 30min, 60min, 90min
Oxygen extraction ratio.
Time frame: Baseline, 30min, 60min, 90min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Results publication: PubMed 26371816Tosoni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Kavanagh, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal blood flow via ECMO machine in people with Extracorporeal Membrane Oxygenation, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (VO2) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.