Transposition of the Great VesselsOxy-CAHNNCT02184169
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
A study testing General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments and Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr in people with Transposition of the Great Vessels and Hypoplastic Left Heart Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, such as vital signs and lactate measurements, to monitor these patients. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Transposition of the Great Vessels, Hypoplastic Left Heart Syndrome, Oxygen Consumption Based Assessment of Hemodynamics
- What is being tested?
- General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments and Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 29 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from birth to 6 months of age
- HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO
- Written parental informed consent
Who cannot join
- Weight < 2 kg
- Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.
- d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.
- Patients on ECMO preoperatively
- Clinically significant tracheo-esophageal fistula or known preoperative air leak
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, such as vital signs and lactate measurements, to monitor these patients. Although they are useful in categorizing patients as well or unwell, these signs currently lack the power quantify a patient's risk for cardiac arrest. More to the point, they are mostly indirect measures of what we really are assessing, which is tissue oxygen delivery.
Our group has significant expertise with devices which quantify the amount of oxygen that a baby consumes every minute. Historically, these values are more commonly used in combination with other measures to assess nutritional and metabolism status. In critically ill patients, however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen their circulation delivers. This may represent a critical relationship, which has been previously described, but not exploited for the purpose of identifying patients with critically low oxygen delivery.
Read more
The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely and precisely measured continuously in newborns undergoing one of two common congenital heart surgeries, (2) to determine whether postoperative circulatory failure is associated with a precedent change in oxygen consumption, and (3) to determine whether the addition of the oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to standardly measured parameters will add power in predicting which patients will experience postoperative circulatory failure.
If successful, this study may improve our capacity to non-invasively and continuously monitor patients following the highest risk congenital heart surgeries, and in the future,to create an algorithm which quantifies a patients risk for having a cardiac arrest. This may permit providers to intervene on these patients earlier, improving the morbidity and mortality associated with congenital heart disease.
- Conditions
- Transposition of the Great Vessels, Hypoplastic Left Heart Syndrome, Oxygen Consumption Based Assessment of Hemodynamics
- Being tested
- General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments, Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
- Keywords
- hemodynamics, neonatal, cardiac disease, congenital heart disease, volumetric oxygen consumption
- Medical subject headings
- Transposition of Great Vessels, Hypoplastic Left Heart Syndrome, Heart Diseases, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 MeasurmentsDevice
Breath to breath VO2 measurements
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 frDevice
Edwards continuous SVO2 measurement system
| Study group | Role | What they receive |
|---|---|---|
| HLHS | Experimental | Patients undergoing palliative repair. Receives: Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments; Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr |
| TGA | Active comparator | Surgical repair of TGA. Receives: Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments; Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption
Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.
Measured: While mechanically ventilated, up to 14 days
Secondary outcomes (1)
Computed Cardiac Index
A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.
Measured: While mechanically ventilated, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2018
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transposition of the Great VesselsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Principal investigator, John Kheir, Boston Children's Hospital
- Investigators
- John Kheir, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184169
- Sponsor's protocol ID
- IRB-P00006630
- Acronym
- Oxy-CAHN
- Status last verified
- Jun 2020
- First submitted
- 2 Jul 2014
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.
PubMed 27806964
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
- ClinicalTrials.gov ID
- NCT02184169
- Acronym / sponsor ID
- Oxy-CAHN / IRB-P00006630
- Conditions
- Transposition of the Great Vessels, Hypoplastic Left Heart Syndrome, Oxygen Consumption Based Assessment of Hemodynamics
- Keywords
- hemodynamics, neonatal, cardiac disease, congenital heart disease, volumetric oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, such as vital signs and lactate measurements, to monitor these patients. Although they are useful in categorizing patients as well or unwell, these signs currently lack the power quantify a patient's risk for cardiac arrest. More to the point, they are mostly indirect measures of what we really are assessing, which is tissue oxygen delivery.
Our group has significant expertise with devices which quantify the amount of oxygen that a baby consumes every minute. Historically, these values are more commonly used in combination with other measures to assess nutritional and metabolism status. In critically ill patients, however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen their circulation delivers. This may represent a critical relationship, which has been previously described, but not exploited for the purpose of identifying patients with critically low oxygen delivery.
The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely and precisely measured continuously in newborns undergoing one of two common congenital heart surgeries, (2) to determine whether postoperative circulatory failure is associated with a precedent change in oxygen consumption, and (3) to determine whether the addition of the oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to standardly measured parameters will add power in predicting which patients will experience postoperative circulatory failure.
If successful, this study may improve our capacity to non-invasively and continuously monitor patients following the highest risk congenital heart surgeries, and in the future,to create an algorithm which quantifies a patients risk for having a cardiac arrest. This may permit providers to intervene on these patients earlier, improving the morbidity and mortality associated with congenital heart disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLHS | Experimental | Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments, Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 frPatients undergoing palliative repair. |
| TGA | Active comparator | Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments, Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 frSurgical repair of TGA. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients from birth to 6 months of age
- HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO
- Written parental informed consent
Key exclusion criteria (5 listed)
- Weight < 2 kg
- Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.
- Patients on ECMO preoperatively
- Clinically significant tracheo-esophageal fistula or known preoperative air leak
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 |
|---|---|---|
| General Electric Healthcare E-COVX Gas Monitoring Module for VO2 MeasurmentsBreath to breath VO2 measurements | Device | HLHS, TGA |
| Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 frEdwards continuous SVO2 measurement system | Device | HLHS, TGA |
Primary outcome
Oxygen Consumption
Time frame: While mechanically ventilated, up to 14 days
Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.
1 secondary outcome
Computed Cardiac Index
Time frame: While mechanically ventilated, up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27806964Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.
- Individual participant dataSharing planned: No
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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.
John Kheir, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments and Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr in people with Transposition of the Great Vessels and Hypoplastic Left Heart Syndrome, run by Boston Children's Hospital at 1 site in United States.
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 3 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 4 Jun 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: While mechanically ventilated, up to 14 days). 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 NCT02184169, 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 4 Jun 2020.