HemoglobinNCT07706140
Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
An observational study of Hemoglobin and Cerebral Oxygenation, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin… Read more about this study
- Who is it for?
- Ages 0 days to 21 years
- Conditions the study is for
- Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease
- What is being tested?
- Noninvasive hemoglobin monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population includes pediatric and adolescent patients under 21 years of age who are scheduled to undergo elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia at Boston Children's Hospital. All participants will have an arterial catheter placed as part of routine clinical care and will receive standard intraoperative physiologic monitoring.
Who may be able to join
- Age less than 21 years at the time of enrollment.
- Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.
- Placement of an arterial catheter as part of routine clinical care for the procedure.
Who cannot join
- Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.
- Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Rachel Bernier, MPH, 857-218-5348, rachel.bernier@childrens.harvard.edu
Jocelyn Booth, BSN, 857-218-4585, jocelyn.booth@childrens.harvard.edu
About this study
Official title: Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care.
The goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.
Read the detailed description
Background:
Continuous monitoring of blood hemoglobin levels may help clinicians identify changes in a patient's blood status during surgery and support decisions regarding blood transfusion. A noninvasive blood hemoglobin monitoring method has been developed using near-infrared spectroscopy (NIRS) technology incorporated into the ForeSight Tissue Oximetry System. This technology uses near-infrared light to measure tissue oxygenation and derive information related to blood hemoglobin levels. An algorithm based on these measurements has been validated and cleared by the U.S. Food and Drug Administration (FDA) for use in adult patients.
Study Purpose:
The purpose of this study is to collect synchronized physiologic and laboratory data from pediatric patients to evaluate the feasibility and performance of applying an FDA-cleared adult blood hemoglobin algorithm to pediatric populations. The study will compare hemoglobin values estimated by the algorithm with reference hemoglobin values measured from arterial blood samples using standard blood-gas/co-oximetry analysis.
Study Design:
This is a prospective observational study conducted at Boston Children's Hospital. Pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia will be eligible for participation. No investigational devices will be used, and participation in the study will not alter routine clinical care.
Study Procedures:
Following enrollment and informed consent, ForeSight tissue oximetry sensors will be placed on the patient's forehead as part of routine monitoring. One or two sensors may be used depending on patient size and available forehead surface area. The sensors will remain in place during the procedure and will continuously record tissue oxygenation and related physiologic signals.
Arterial blood samples obtained as part of routine clinical care will be used to measure blood hemoglobin levels using a blood-gas/co-oximetry analyzer. In some patients, up to two additional blood samples may be collected to strengthen the evaluation dataset. The amount of blood collected for these additional samples will be minimal.
Additional data collected will include demographic information, procedure type, standard physiologic monitoring parameters (such as heart rate, blood pressure, oxygen saturation, respiratory measurements, and temperature), laboratory values, administered medications and blood products, and clinically significant hemodynamic events documented during the procedure.
Data Handling:
Data collected from the monitoring system and clinical records will be linked and subsequently de-identified by authorized study personnel. Personal identifiers will be removed before data are shared with the study sponsor. The sponsor will have access only to de-identified study data.
Outcome Evaluation:
The primary objective is to assess the agreement between hemoglobin values estimated by the NIRS-based algorithm and reference hemoglobin values measured from arterial blood samples. Study analyses will evaluate the accuracy, bias, precision, and agreement of algorithm-derived hemoglobin measurements in pediatric patients. The results will help determine whether the adult FDA-cleared algorithm performs adequately in pediatric populations and will provide information to guide future clinical evaluation and regulatory activities related to noninvasive hemoglobin monitoring in children and adolescents.
- Conditions
- Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease
- Being tested
- Noninvasive hemoglobin monitoring
- Keywords
- pediatric cardiac surgery, pediatric cardiac catheterization, transfusion guidance, noninvasive hemoglobin monitoring, near-infrared spectroscopy NIRS monitoring, tissue oximetry, ForeSight system, HemoSphere monitor, algorithm validation, arterial blood gas comparison
- 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.
Noninvasive hemoglobin monitoringDevice
This study evaluates noninvasive hemoglobin monitoring using a near-infrared spectroscopy (NIRS)-based tissue oximetry system in pediatric patients undergoing cardiac surgery or cardiac catheterization under general anesthesia.
A FDA-cleared ForeSight Tissue Oximetry sensor is placed on the forehead to continuously measure tissue oxygenation, and an algorithm is derived to estimate hemoglobin.
Reference hemoglobin values are obtained from arterial blood samples analyzed using standard blood-gas/co-oximetry methods as part of routine clinical care. A small number of additional samples may be collected if needed.
The study compares noninvasive hemoglobin estimates with laboratory hemoglobin measurements. No investigational devices are used, and there is no change to clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Cardiac Surgery and Pediatric Catheterization Patients | This cohort includes pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization under general anesthesia. All participants receive standard clinical care, including routine physiologic monitoring and arterial blood sampling when clinically indicated.
As part of routine monitoring, a FDA-cleared near-infrared spectroscopy (NIRS)-based tissue oximetry system (ForeSight Tissue Oximetry System) will be placed on the forehead to continuously record cerebral tissue oxygenation during the procedure.
Arterial blood samples obtained for clinical care will be analyzed using standard blood-gas/co-oximetry methods to measure blood hemoglobin levels. In select cases, a small number of additional blood samples may be collected to support data analysis.
This is an observational study only. No investigational devices are used, no interventions are assigned, and there is no change to clinical management. All collected data are de-identified prior to analysis. Receives: Device: Noninvasive hemoglobin monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Noninvasive and Invasive Hemoglobin Measurements
The primary outcome measure is the agreement between NIRS-estimated hemoglobin and hemoglobin measured from arterial blood samples. Both assessments measure hemoglobin concentration and will be reported in grams per deciliter (g/dL). Agreement will be assessed by comparing paired hemoglobin measurements from the two methods. The reported outcome will include the mean difference between the two measurements (g/dL) and the range of differences observed (g/dL).
Measured: Intraoperative period (from induction of general anesthesia until end of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemoglobinStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Principal investigator, Dima Daaboul, Boston Children's Hospital
- Investigators
- Dima Daaboul, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706140
- Sponsor's protocol ID
- IRB-P00054090
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The protocol does not include plans to share individual participant data with external researchers. Only deidentified data will be used by the study investigators and sponsor for study-related analyses.
Publications
Kussman BD, Wypij D, DiNardo JA, Newburger J, Jonas RA, Bartlett J, McGrath E, Laussen PC. An evaluation of bilateral monitoring of cerebral oxygen saturation during pediatric cardiac surgery. Anesth Analg. 2005 Nov;101(5):1294-1300. doi: 10.1213/01.ANE.0000180205.85490.85.
PubMed 16243983van Wonderen SF, Aguirre A, Benni P, van den Dool REC, Macias Pingarron JP, Solares GJ, Hatib F, Veelo DP, Vlaar APJ, Jian Z. Continuous and Noninvasive Total Blood Hemoglobin Measurement Using Near-Infrared Reflectance Spectrometry. Anesth Analg. 2025 Nov 1;141(5):1107-1115. doi: 10.1213/ANE.0000000000007618. Epub 2025 Jul 2.
PubMed 40601488
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Data Collection Study for Validation of a Near-Infrared Spectroscopy-Based Blood Hemoglobin Algorithm in Pediatric Patients Undergoing Cardiac Surgery or Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT07706140
- Acronym / sponsor ID
- IRB-P00054090
- Conditions
- Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease
- Keywords
- pediatric cardiac surgery, pediatric cardiac catheterization, transfusion guidance, noninvasive hemoglobin monitoring, near-infrared spectroscopy NIRS monitoring, tissue oximetry, ForeSight system, HemoSphere monitor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- 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.
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia. Researchers will collect information from a forehead sensor that measures oxygen levels in the body's tissues, along with blood hemoglobin measurements obtained from blood samples that are already being collected as part of routine medical care.
The goal of the study is to determine whether a blood hemoglobin monitoring method that has already been cleared by the U.S. Food and Drug Administration (FDA) for use in adults may also work well in pediatric patients.
Detailed description
Background:
Continuous monitoring of blood hemoglobin levels may help clinicians identify changes in a patient's blood status during surgery and support decisions regarding blood transfusion. A noninvasive blood hemoglobin monitoring method has been developed using near-infrared spectroscopy (NIRS) technology incorporated into the ForeSight Tissue Oximetry System. This technology uses near-infrared light to measure tissue oxygenation and derive information related to blood hemoglobin levels. An algorithm based on these measurements has been validated and cleared by the U.S. Food and Drug Administration (FDA) for use in adult patients.
Study Purpose:
The purpose of this study is to collect synchronized physiologic and laboratory data from pediatric patients to evaluate the feasibility and performance of applying an FDA-cleared adult blood hemoglobin algorithm to pediatric populations. The study will compare hemoglobin values estimated by the algorithm with reference hemoglobin values measured from arterial blood samples using standard blood-gas/co-oximetry analysis.
Study Design:
This is a prospective observational study conducted at Boston Children's Hospital. Pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia will be eligible for participation. No investigational devices will be used, and participation in the study will not alter routine clinical care.
Study Procedures:
Following enrollment and informed consent, ForeSight tissue oximetry sensors will be placed on the patient's forehead as part of routine monitoring. One or two sensors may be used depending on patient size and available forehead surface area. The sensors will remain in place during the procedure and will continuously record tissue oxygenation and related physiologic signals.
Arterial blood samples obtained as part of routine clinical care will be used to measure blood hemoglobin levels using a blood-gas/co-oximetry analyzer. In some patients, up to two additional blood samples may be collected to strengthen the evaluation dataset. The amount of blood collected for these additional samples will be minimal.
Additional data collected will include demographic information, procedure type, standard physiologic monitoring parameters (such as heart rate, blood pressure, oxygen saturation, respiratory measurements, and temperature), laboratory values, administered medications and blood products, and clinically significant hemodynamic events documented during the procedure.
Data Handling:
Data collected from the monitoring system and clinical records will be linked and subsequently de-identified by authorized study personnel. Personal identifiers will be removed before data are shared with the study sponsor. The sponsor will have access only to de-identified study data.
Outcome Evaluation:
The primary objective is to assess the agreement between hemoglobin values estimated by the NIRS-based algorithm and reference hemoglobin values measured from arterial blood samples. Study analyses will evaluate the accuracy, bias, precision, and agreement of algorithm-derived hemoglobin measurements in pediatric patients. The results will help determine whether the adult FDA-cleared algorithm performs adequately in pediatric populations and will provide information to guide future clinical evaluation and regulatory activities related to noninvasive hemoglobin monitoring in children and adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Cardiac Surgery and Pediatric Catheterization Patients | – | Device: Noninvasive hemoglobin monitoringThis cohort includes pediatric patients undergoing elective cardiac surgery or elective cardiac catheterization under general anesthesia. All participants receive standard clinical care, including routine physiologic monitoring and arterial blood sampling when clinically indicated. As part of routine monitoring, a FDA-cleared near-infrared spectroscopy (NIRS)-based tissue oximetry system (ForeSight Tissue Oximetry System) will be placed on the forehead to continuously record cerebral tissue oxygenation during the procedure. Arterial blood samples obtained for clinical care will be analyzed using standard blood-gas/co-oximetry methods to measure blood hemoglobin levels. In select cases, a small number of additional blood samples may be collected to support data analysis. This is an observational study only. No investigational devices are used, no interventions are assigned, and there is no change to clinical management. All collected data are de-identified prior to analysis. |
Who may qualify
- Ages
- 0 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population includes pediatric and adolescent patients under 21 years of age who are scheduled to undergo elective cardiac surgery or elective cardiac catheterization procedures under general anesthesia at Boston Children's Hospital. All participants will have an arterial catheter placed as part of routine clinical care and will receive standard intraoperative physiologic monitoring.
Key inclusion criteria (3 listed)
- Age less than 21 years at the time of enrollment.
- Scheduled for elective cardiac surgery or elective cardiac catheterization under general anesthesia.
- Placement of an arterial catheter as part of routine clinical care for the procedure.
Key exclusion criteria (2 listed)
- Presence of skin, scalp, or craniofacial abnormalities that prevent proper placement of the near-infrared spectroscopy (NIRS) sensor or may significantly affect measurement quality.
- Inability to obtain arterial blood hemoglobin measurements using standard clinical methods.
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 |
|---|---|---|
| Noninvasive hemoglobin monitoringThis study evaluates noninvasive hemoglobin monitoring using a near-infrared spectroscopy (NIRS)-based tissue oximetry system in pediatric patients undergoing cardiac surgery or cardiac catheterization under general anesthesia. A FDA-cleared ForeSight Tissue Oximetry sensor is placed on the forehead to continuously measure tissue oxygenation, and an algorithm is derived to estimate hemoglobin. Reference hemoglobin values are obtained from arterial blood samples analyzed using standard blood-gas/co-oximetry methods as part of routine clinical care. A small number of additional samples may be collected if needed. The study compares noninvasive hemoglobin estimates with laboratory hemoglobin measurements. No investigational devices are used, and there is no change to clinical care. | Device | Pediatric Cardiac Surgery and Pediatric Catheterization Patients |
Primary outcome
Agreement Between Noninvasive and Invasive Hemoglobin Measurements
Time frame: Intraoperative period (from induction of general anesthesia until end of procedure)
The primary outcome measure is the agreement between NIRS-estimated hemoglobin and hemoglobin measured from arterial blood samples. Both assessments measure hemoglobin concentration and will be reported in grams per deciliter (g/dL). Agreement will be assessed by comparing paired hemoglobin measurements from the two methods. The reported outcome will include the mean difference between the two measurements (g/dL) and the range of differences observed (g/dL).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 16243983Kussman BD, Wypij D, DiNardo JA, Newburger J, Jonas RA, Bartlett J, McGrath E, Laussen PC. An evaluation of bilateral monitoring of cerebral oxygen saturation during pediatric cardiac surgery. Anesth Analg. 2005 Nov;101(5):1294-1300. doi: 10.1213/01.ANE.0000180205.85490.85.
- Background: PubMed 40601488van Wonderen SF, Aguirre A, Benni P, van den Dool REC, Macias Pingarron JP, Solares GJ, Hatib F, Veelo DP, Vlaar APJ, Jian Z. Continuous and Noninvasive Total Blood Hemoglobin Measurement Using Near-Infrared Reflectance Spectrometry. Anesth Analg. 2025 Nov 1;141(5):1107-1115. doi: 10.1213/ANE.0000000000007618. Epub 2025 Jul 2.
- Manufacturer information for the HemoSphere advanced patient monitoring platform used to acquire tissue oximetry and hemodynamic data in this study.Link provided by the sponsor.
- Manufacturer information for the ForeSight tissue oximetry sensor, which provides continuous noninvasive cerebral tissue oxygenation monitoring and tissue hemoglobin measurements used in this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The protocol does not include plans to share individual participant data with external researchers. Only deidentified data will be used by the study investigators and sponsor for study-related analyses.
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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.
Dima Daaboul 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?
An observational study of Hemoglobin and Cerebral Oxygenation, 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 2 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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dima Daaboul, MD ((617) 355-1370, dima.daaboul@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Noninvasive and Invasive Hemoglobin Measurements (time frame: Intraoperative period (from induction of general anesthesia until end of procedure)). 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 NCT07706140, which also lists 2 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 27 Jul 2026.