Congenital Heart DiseaseNCT00556231
Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
An observational study of Congenital Heart Disease, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2012
- Phase
- Observational
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents from age 6 to 20 undergoing exercise stress testing
Who may be able to join
- Children and adolescents from age 6 to 20 undergoing exercise stress testing on treadmill
Who cannot join
- Children and adolescents unable to exercise or unable to follow directions or unable to understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Global Hemodynamic Assessment During Exercise Testing in Children With and Without Heart Disease
Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and hemoglobin without oxygen.
During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by comparing the amount of oxygen available to discrete regions of the body nourished by different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen available to the brain (cerebral), while leads placed over the kidney reflect oxygen available to the internal organs (somatic).
Read more
NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying cardiac output through the patterning of somatic and cerebral oxygenation in combination with exercise stress test data has not been researched.
We hypothesize that addition of multi-site NIRS monitoring to the standard data collection already achieved during exercise testing, will enable calculation of anaerobic threshold and cardiac output prediction. This will assist in determining appropriate timing for surgical intervention, predicting the post operative course and testing response to medication.
- Conditions
- Congenital Heart Disease
- Keywords
- NIRS, cardiac output, anaerobic threshold, exercise stress, congenital heart defect
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children with congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test | |
| 2 | Children without congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test | |
| 3 | Not described | |
| 4 | Not described | |
| 5 | Not described | |
| 6 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional oxygen saturations in 4 sites
Measured: during exercise stress testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, John Hambrook, Medical College of Wisconsin
- Investigators
- John Hambrook, MD, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556231
- Sponsor's protocol ID
- CHW 07/198
- Status last verified
- Jan 2013
- First submitted
- 7 Nov 2007
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Danduran MJ, Dixon JE, Rao RP. Near infrared spectroscopy describes physiologic payback associated with excess postexercise oxygen consumption in healthy controls and children with complex congenital heart disease. Pediatr Cardiol. 2012 Jan;33(1):95-102. doi: 10.1007/s00246-011-0097-3. Epub 2011 Sep 3.
PubMed 21892649Rao RP, Danduran MJ, Loomba RS, Dixon JE, Hoffman GM. Near-infrared spectroscopic monitoring during cardiopulmonary exercise testing detects anaerobic threshold. Pediatr Cardiol. 2012 Jun;33(5):791-6. doi: 10.1007/s00246-012-0217-8. Epub 2012 Feb 19.
PubMed 22349729Rao RP, Danduran MJ, Hoffman GM, Ghanayem NS, Berger S, Frommelt PC. Cerebral hemodynamics in the presence of decreased systemic venous compliance in patients with Fontan physiology may limit anaerobic exercise capacity. Pediatr Cardiol. 2010 Feb;31(2):208-14. doi: 10.1007/s00246-009-9585-0.
PubMed 19915888
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Global Hemodynamic Assessment During Exercise Testing in Children With and Without Heart Disease
- ClinicalTrials.gov ID
- NCT00556231
- Acronym / sponsor ID
- CHW 07/198
- Conditions
- Congenital Heart Disease
- Keywords
- NIRS, cardiac output, anaerobic threshold, exercise stress, congenital heart defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Nov 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Nov 2007 (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.
Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and hemoglobin without oxygen.
During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by comparing the amount of oxygen available to discrete regions of the body nourished by different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen available to the brain (cerebral), while leads placed over the kidney reflect oxygen available to the internal organs (somatic).
NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying cardiac output through the patterning of somatic and cerebral oxygenation in combination with exercise stress test data has not been researched.
We hypothesize that addition of multi-site NIRS monitoring to the standard data collection already achieved during exercise testing, will enable calculation of anaerobic threshold and cardiac output prediction. This will assist in determining appropriate timing for surgical intervention, predicting the post operative course and testing response to medication.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Children with congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test |
| 2 | – | –Children without congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test |
| 3 | – | – |
| 4 | – | – |
| 5 | – | – |
| 6 | – | – |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents from age 6 to 20 undergoing exercise stress testing
Key inclusion criteria (1 listed)
- Children and adolescents from age 6 to 20 undergoing exercise stress testing on treadmill
Key exclusion criteria (1 listed)
- Children and adolescents unable to exercise or unable to follow directions or unable to understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
regional oxygen saturations in 4 sites
Time frame: during exercise stress testing
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 4 Jan 2013.
- Results publication: PubMed 21892649Danduran MJ, Dixon JE, Rao RP. Near infrared spectroscopy describes physiologic payback associated with excess postexercise oxygen consumption in healthy controls and children with complex congenital heart disease. Pediatr Cardiol. 2012 Jan;33(1):95-102. doi: 10.1007/s00246-011-0097-3. Epub 2011 Sep 3.
- Results publication: PubMed 22349729Rao RP, Danduran MJ, Loomba RS, Dixon JE, Hoffman GM. Near-infrared spectroscopic monitoring during cardiopulmonary exercise testing detects anaerobic threshold. Pediatr Cardiol. 2012 Jun;33(5):791-6. doi: 10.1007/s00246-012-0217-8. Epub 2012 Feb 19.
- Derived from this study: PubMed 19915888Rao RP, Danduran MJ, Hoffman GM, Ghanayem NS, Berger S, Frommelt PC. Cerebral hemodynamics in the presence of decreased systemic venous compliance in patients with Fontan physiology may limit anaerobic exercise capacity. Pediatr Cardiol. 2010 Feb;31(2):208-14. doi: 10.1007/s00246-009-9585-0.
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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 Hambrook, MD principal investigator
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Medical College of Wisconsin 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 1 inclusion and 1 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 Jan 2013. 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?
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?
regional oxygen saturations in 4 sites (time frame: during exercise stress testing). 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 NCT00556231, which also lists 3 linked publications.
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 Jan 2013.