Cardiopulmonary BypassNIRSNCT00745394
Validation of Near Infrared Spectroscopy (NIRS) During Heart-Lung Bypass in Children
An observational study of Cardiopulmonary Bypass, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiopulmonary Bypass
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 31 Dec 2008
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who undergo surgical correction of their congenital heart disease that require cardiopulmonary bypass.
Who may be able to join
- 1. Patients that require cardiopulmonary bypass during surgical correction of heart disease
- 2. Prospective, Informed Consent
Who cannot join
- 1. Patients with malformations of venous return to the heart (e.g. interrupted IVC with azygous continuation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Somatic and Cerebral Near Infrared Spectroscopy (NIRS) During Cardiopulmonary Bypass In Pediatric Patients: A Prospective Clinical Study
Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in widespread use in the clinical care of pediatric cardiac patients in the operating room and in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on the forehead or lower back, blood oxygen concentration data is obtained which has been found to correlate with actual blood samples taken by IV. The presence of this NIRS data would give the surgeon important feedback about blood flow to important areas like the brain and kidneys during heart surgeries on children and after the operation is completed in the intensive care unit.
The investigator wishes to perform a prospective study of the NIRS monitor use with children that need heart surgeries that require heart-lung bypass and sometimes require monitoring in the ICU, post-operatively.
Read the detailed description
After patients are prospectively consented pre-operatively, standard medical care, including the use of the NIRS monitor, will be implemented during the patient's operation and post-operatively in the intensive care unit with few modifications. These modifications include: (1) the placement of an oximetric probe in the lumen of the cardiopulmonary bypass circuit tubing which will output continuous blood oxygen content during bypass, (2) the addition of extra connectors to the bypass tubing to allow blood draws during surgery, (3) placement of doppler blood flow probes on the tubing to measure blood flow velocity, and (4) the addition of LFTs during the post-operative phase, if followed. Patients that receive operations that require circulatory arrest and/or selective cerebral perfusion will be followed in the ICU for 5 days. Data from the bypass machine along, data collected from the NIRS and oximetric probe monitor, and serum data will be interfaced into a data collection system.
Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), NIRS data, serum blood gas data, serum lactate levels, hemoglobin levels, vital signs, doppler blood flow data, LFT analysis, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results.
The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, operation performed, post-operative course, and outcome. Validation of the use of the NIRS monitor and further characterization of the NIRS monitor will also be sought.
Notes: 1/15/2025 -Record transferred from Ann \& Robert H Lurie Children's Hospital of Chicago to University of Texas Southwestern Medical Center since Record shows UTSW as the Sponsor. Dr. Forbess (Responsible Party) and his team for this study no longer at UTSW to shed light on why this record was transferred to Lurie Children's in 2019. Dr. Jaquiss from Cardiovascular \& Thoracic Surgery Department at UTSW confirmed on 1/7/2025 that - "No patient has been enrolled in this study and should be considered to be closed".
- Conditions
- Cardiopulmonary Bypass
- Keywords
- NIRS, bypass, cardiopulmonary, CPB, monitoring, system
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine correlation between cerebral/somatic NIRS saturation data obtained on CPB and oxygen saturation and lactate data obtained from the superior vena caval (SVC) blood.
Measured: Length of surgery with possible 5 day follow-up in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completion31 Dec 2008
Why it stopped: No patient has been enrolled in this study for more than 8 years. Study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Responsible party
- Sponsor
- Investigators
- Joseph Forbess, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745394
- Sponsor's protocol ID
- 072007-057
- Acronym
- NIRS
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2008
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Somatic and Cerebral Near Infrared Spectroscopy (NIRS) During Cardiopulmonary Bypass In Pediatric Patients: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT00745394
- Acronym / sponsor ID
- NIRS / 072007-057
- Conditions
- Cardiopulmonary Bypass
- Keywords
- NIRS, bypass, cardiopulmonary, CPB, monitoring, system
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patient has been enrolled in this study for more than 8 years. Study closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 3 Sep 2008 (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.
Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in widespread use in the clinical care of pediatric cardiac patients in the operating room and in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on the forehead or lower back, blood oxygen concentration data is obtained which has been found to correlate with actual blood samples taken by IV. The presence of this NIRS data would give the surgeon important feedback about blood flow to important areas like the brain and kidneys during heart surgeries on children and after the operation is completed in the intensive care unit.
The investigator wishes to perform a prospective study of the NIRS monitor use with children that need heart surgeries that require heart-lung bypass and sometimes require monitoring in the ICU, post-operatively.
Detailed description
After patients are prospectively consented pre-operatively, standard medical care, including the use of the NIRS monitor, will be implemented during the patient's operation and post-operatively in the intensive care unit with few modifications. These modifications include: (1) the placement of an oximetric probe in the lumen of the cardiopulmonary bypass circuit tubing which will output continuous blood oxygen content during bypass, (2) the addition of extra connectors to the bypass tubing to allow blood draws during surgery, (3) placement of doppler blood flow probes on the tubing to measure blood flow velocity, and (4) the addition of LFTs during the post-operative phase, if followed. Patients that receive operations that require circulatory arrest and/or selective cerebral perfusion will be followed in the ICU for 5 days. Data from the bypass machine along, data collected from the NIRS and oximetric probe monitor, and serum data will be interfaced into a data collection system.
Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), NIRS data, serum blood gas data, serum lactate levels, hemoglobin levels, vital signs, doppler blood flow data, LFT analysis, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results.
The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, operation performed, post-operative course, and outcome. Validation of the use of the NIRS monitor and further characterization of the NIRS monitor will also be sought.
Notes: 1/15/2025 -Record transferred from Ann \& Robert H Lurie Children's Hospital of Chicago to University of Texas Southwestern Medical Center since Record shows UTSW as the Sponsor. Dr. Forbess (Responsible Party) and his team for this study no longer at UTSW to shed light on why this record was transferred to Lurie Children's in 2019. Dr. Jaquiss from Cardiovascular \& Thoracic Surgery Department at UTSW confirmed on 1/7/2025 that - "No patient has been enrolled in this study and should be considered to be closed".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who undergo surgical correction of their congenital heart disease that require cardiopulmonary bypass.
Key inclusion criteria (2 listed)
- 1. Patients that require cardiopulmonary bypass during surgical correction of heart disease
- 2. Prospective, Informed Consent
Key exclusion criteria (1 listed)
- 1. Patients with malformations of venous return to the heart (e.g. interrupted IVC with azygous continuation).
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
Determine correlation between cerebral/somatic NIRS saturation data obtained on CPB and oxygen saturation and lactate data obtained from the superior vena caval (SVC) blood.
Time frame: Length of surgery with possible 5 day follow-up in the ICU
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
Joseph Forbess, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
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 Cardiopulmonary Bypass, run by University of Texas Southwestern Medical Center 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 2 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: withdrawn, as of the sponsor's last update on 24 Jan 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Determine correlation between cerebral/somatic NIRS saturation data obtained on CPB and oxygen saturation and lactate data obtained from the superior vena caval (SVC) blood. (time frame: Length of surgery with possible 5 day follow-up in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.