Unstable Blood PressureNCT06994494
Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
An observational study of Unstable Blood Pressure and Hypotension, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this study is to evaluate if a novel near-infrared spectroscopy (NIRS) device can accurately estimate blood pressure in newborns at risk for unstable blood pressure. The main questions it aims to answer are: Can NIRS accurately estimate blood pressure when compared to the gold standard, arterial line blood… Read more about this study
- Who is it for?
- Ages 24 to 44 weeks
- Conditions the study is for
- Unstable Blood Pressure, Hypotension
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2025to 30 Nov 2026
- 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 24 to 44 weeks
- All sexes
- Child
Study population: The study population will include 80 neonates of ≥24 weeks and <44 weeks postmenstrual age, with or without A-line BP monitoring for clinical reasons. Subjects will be recruited from the Neonatal Intensive Care Unit at MGH and BWH.
Who may be able to join
- Neonates ≥24 \& <44 weeks postmenstrual age
- Hospitalization in MGH or BWH newborn service units
- For A-line BP monitoring: Neonates expected to maintain A-line monitoring for at least the next 12 hours
- For non-A-line monitoring: Neonates at risk for unstable blood pressure (e.g. clinical instability or need for inotropes) and no contraindications to manual cuff BP measurements every 1 to 4 hours
Who cannot join
- Contraindication to FlexNIRS device placement on the scalp/head
- Underlying congenital/genetic anomalies
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusettes General Hospital
Boston, Massachusetts, 02114
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this study is to evaluate if a novel near-infrared spectroscopy (NIRS) device can accurately estimate blood pressure in newborns at risk for unstable blood pressure. The main questions it aims to answer are:
- Can NIRS accurately estimate blood pressure when compared to the gold standard, arterial line blood pressure
- Can NIRS accurately estimate blood pressure when compared to infants with cuff blood pressure monitoring
Read more
Researchers will compare NIRS-based estimates to arterial line blood pressure readings and manual cuff measurements to optimize and validate the FlexNIRS device for neonates to accurately estimate blood pressure continuously and noninvasively.
Participants will wear a small, noninvasive NIRS sensor on the forehead.
Read the detailed description
Continuous blood pressure monitoring is important for critically ill newborns to prevent brain injury caused by dysregulated changes in cerebral perfusion. In addition, continuous blood pressure monitoring is beneficial to management of many other conditions in neonates: including hypoxic-ischemic encephalopathy; for monitoring respiratory issues such as respiratory distress syndrome and pulmonary hypertension related to meconium aspiration syndrome; for managing the vascular resistance in conditions like patent ductus arteriosus and congenital heart failures; for ensuring adequate tissue perfusion during critical illness like sepsis and necrotizing enterocolitis (NEC); and for maintaining vascular tone when using inotropes or vasopressors.
The gold standard for continuous BP monitoring in newborns is via arterial line (A-line BP). However, it involves catheterization of the umbilical or a peripheral artery and can lead to complications such as vasospasm, nerve damage, ischemia, thrombosis, and, in severe cases, limb amputation. Due to these risks, A-line BP monitoring is only used when deemed necessary in critically ill neonates.
Existing noninvasive alternatives, including volume-clamp photoplethysmography cuffs, pulse-transit-time, and tonography, are problematic due to large error and safety concerns. They have been validated primarily for adults and are not tailored for neonates who pose unique challenges due to their fragile limbs, underdeveloped vasculature, immature cardiac function, and mean arterial BP often being less than a third of an adult's (30 mmHg).
To address this critical need for accurate, continuous, and noninvasive BP monitoring in newborns, the study team proposes employing a near-infrared spectroscopy (NIRS) technique on the head, focusing on pulsation tones and shapes in cerebral hemodynamics, which are sensitive to BP changes. The team has developed a wearable, battery-operated NIRS device, called FlexNIRS, capable of providing continuous photoplethysmogram (PPG) with a high temporal resolution of 266 Hz. In adults, the team has shown that the time derivative of its optical pulse waveforms d/dt(PPG) is related to pulsatile blood flow, and found strong correlations between specific features of d/dt(NIRS-PPG) and blood pressure changes. Based on these findings, it is hypothesized that NIRS-PPG collected in the brain is most ideal for neonates, especially given their fragile peripheries, and the head site allowing more robust measure of deep brain with less external factors, such as pressure from the sensor itself, room temperature, and extra arterial resistance that builds up in local peripheries. Importantly, the study team has tested the FlexNIRS in a preterm newborn and found pulsatile morphology patterns comparable to those in adults.
The current study aims to validate this novel technique for BP assessment in the newborn population from up to 80 newborns, divided evenly across Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH). Each measurement will involve monitoring infants with one or two FlexNIRS devices for 3-24 hours a day, for at least one day. This data will be used to refine the study team's FlexNIRS-based blood pressure estimation algorithms and correlate results with invasive A-line BP as the gold standard or periodic BP cuff readings performed by clinical staff. This research will provide invaluable data demonstrating method feasibility and initial clinical utility. The successful execution of this aim will guide the study team to a larger clinical study.
- Conditions
- Unstable Blood Pressure, Hypotension
- Keywords
- Non-invasive blood pressure monitoring, Arterial Line, NIRS, wearable device, Cerebral oximetry
- Medical subject headings
- Hypotension
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 |
|---|---|---|
| Arterial Line Cohort | We will recruit and measure neonates who are between ≥ 24 weeks and < 44 weeks postmenstrual age, undergoing A-line BP monitoring for clinical reasons. | |
| Cuff Cohort | We will recruit and measure neonates in the same age range as in the A-line cohort who are at risk for unstable blood pressure but without A-line BP monitoring, as long as they can tolerate manual cuff-based BP measurements at intervals of at least 1-4 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FlexNIRS-based blood pressure estimation
Determine the correlation between FlexNIRS based blood pressure estimation and invasive A-line blood pressure as the gold standard or periodic BP cuff readings performed by clinical staff.
Measured: 04/09/2025 - 11/30/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start9 Apr 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Unstable Blood PressureStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Emily M. Herzberg, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994494
- Sponsor's protocol ID
- 2024P000562
- Other IDs
- 1R21HD117308-01
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded and deidentified data may be shared with collaborators outside of Mass General Brigham. All external data sharing will be tracked and logged, and upon request, this information will be readily available to the subjects. The PI will supervise daily lab/team data management and sharing activities, ensuring strict adherence to the data sharing policies outlined by MGB. No identifiable data will be shared or received from collaborators outside of Mass General Brigham.
Publications
Wu KC, Martin A, Renna M, Robinson M, Ozana N, Carp SA, Franceschini MA. Enhancing diffuse correlation spectroscopy pulsatile cerebral blood flow signal with near-infrared spectroscopy photoplethysmography. Neurophotonics. 2023 Jul;10(3):035008. doi: 10.1117/1.NPh.10.3.035008. Epub 2023 Sep 6.
PubMed 37680339Wu KC, Tamborini D, Renna M, Peruch A, Huang Y, Martin A, Kaya K, Starkweather Z, Zavriyev AI, Carp SA, Salat DH, Franceschini MA. Open-source FlexNIRS: A low-cost, wireless and wearable cerebral health tracker. Neuroimage. 2022 Aug 1;256:119216. doi: 10.1016/j.neuroimage.2022.119216. Epub 2022 Apr 19.
PubMed 35452803Boas DA, Strangman G, Culver JP, Hoge RD, Jasdzewski G, Poldrack RA, Rosen BR, Mandeville JB. Can the cerebral metabolic rate of oxygen be estimated with near-infrared spectroscopy? Phys Med Biol. 2003 Aug 7;48(15):2405-18. doi: 10.1088/0031-9155/48/15/311.
PubMed 12953906Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
PubMed 20007987Gonzalez S, Hsieh WT, Chen TP. A benchmark for machine-learning based non-invasive blood pressure estimation using photoplethysmogram. Sci Data. 2023 Mar 21;10(1):149. doi: 10.1038/s41597-023-02020-6.
PubMed 36944668Troy R, Doron M, Laughon M, Tolleson-Rinehart S, Price W. Comparison of noninvasive and central arterial blood pressure measurements in ELBW infants. J Perinatol. 2009 Nov;29(11):744-9. doi: 10.1038/jp.2009.86. Epub 2009 Jul 16.
PubMed 19609309Dionne JM. Determinants of Blood Pressure in Neonates and Infants: Predictable Variability. Hypertension. 2021 Mar 3;77(3):781-787. doi: 10.1161/HYPERTENSIONAHA.120.14587. Epub 2021 Feb 10.
PubMed 33566691Rao A, Eskandar-Afshari F, Weiner Y, Billman E, McMillin A, Sella N, Roxlo T, Liu J, Leong W, Helfenbein E, Walendowski A, Muir A, Joseph A, Verma A, Ramamoorthy C, Honkanen A, Green G, Drake K, Govindan RB, Rhine W, Quan X. Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates. Sensors (Basel). 2023 Apr 2;23(7):3690. doi: 10.3390/s23073690.
PubMed 37050750Alonzo CJ, Nagraj VP, Zschaebitz JV, Lake DE, Moorman JR, Spaeder MC. Blood pressure ranges via non-invasive and invasive monitoring techniques in premature neonates using high resolution physiologic data. J Neonatal Perinatal Med. 2020;13(3):351-358. doi: 10.3233/NPM-190260.
PubMed 31771082Lynch TM. Invasive and noninvasive pressure monitoring in neonates. J Perinat Neonatal Nurs. 1987 Jul;1(1):58-71. doi: 10.1097/00005237-198707000-00010. No abstract available.
PubMed 3451967Hahn GH, Hyttel-Sorensen S, Petersen SM, Pryds O, Greisen G. Cerebral effects of commonly used vasopressor-inotropes: a study in newborn piglets. PLoS One. 2013 May 20;8(5):e63069. doi: 10.1371/journal.pone.0063069. Print 2013.
PubMed 23700412Turner MA, Baines P. Which inotrope and when in neonatal and paediatric intensive care? Arch Dis Child Educ Pract Ed. 2011 Dec;96(6):216-22. doi: 10.1136/adc.2008.143925. Epub 2011 Aug 3. No abstract available.
PubMed 21813560Rhee CJ, da Costa CS, Austin T, Brady KM, Czosnyka M, Lee JK. Neonatal cerebrovascular autoregulation. Pediatr Res. 2018 Nov;84(5):602-610. doi: 10.1038/s41390-018-0141-6. Epub 2018 Sep 8.
PubMed 30196311Selb J, Wu KC, Sutin J, Lin PI, Farzam P, Bechek S, Shenoy A, Patel AB, Boas DA, Franceschini MA, Rosenthal ES. Prolonged monitoring of cerebral blood flow and autoregulation with diffuse correlation spectroscopy in neurocritical care patients. Neurophotonics. 2018 Oct;5(4):045005. doi: 10.1117/1.NPh.5.4.045005. Epub 2018 Nov 13.
PubMed 30450363Sunwoo J, Zavriyev AI, Kaya K, Martin A, Munster C, Steele T, Cuddyer D, Sheldon Y, Orihuela-Espina F, Herzberg EM, Inder T, Franceschini MA, El-Dib M. Diffuse correlation spectroscopy blood flow monitoring for intraventricular hemorrhage vulnerability in extremely low gestational age newborns. Sci Rep. 2022 Jul 27;12(1):12798. doi: 10.1038/s41598-022-16499-3.
PubMed 35896691
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Continuous BP Monitoring in Newborns Based on Pulsatile Signal Morphological Features Using NIRS
- ClinicalTrials.gov ID
- NCT06994494
- Acronym / sponsor ID
- 2024P000562
- Conditions
- Unstable Blood Pressure, Hypotension
- Keywords
- Non-invasive blood pressure monitoring, Arterial Line, NIRS, wearable device, Cerebral oximetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 May 2025 (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.
The goal of this study is to evaluate if a novel near-infrared spectroscopy (NIRS) device can accurately estimate blood pressure in newborns at risk for unstable blood pressure. The main questions it aims to answer are:
- Can NIRS accurately estimate blood pressure when compared to the gold standard, arterial line blood pressure
- Can NIRS accurately estimate blood pressure when compared to infants with cuff blood pressure monitoring
Researchers will compare NIRS-based estimates to arterial line blood pressure readings and manual cuff measurements to optimize and validate the FlexNIRS device for neonates to accurately estimate blood pressure continuously and noninvasively.
Participants will wear a small, noninvasive NIRS sensor on the forehead.
Detailed description
Continuous blood pressure monitoring is important for critically ill newborns to prevent brain injury caused by dysregulated changes in cerebral perfusion. In addition, continuous blood pressure monitoring is beneficial to management of many other conditions in neonates: including hypoxic-ischemic encephalopathy; for monitoring respiratory issues such as respiratory distress syndrome and pulmonary hypertension related to meconium aspiration syndrome; for managing the vascular resistance in conditions like patent ductus arteriosus and congenital heart failures; for ensuring adequate tissue perfusion during critical illness like sepsis and necrotizing enterocolitis (NEC); and for maintaining vascular tone when using inotropes or vasopressors.
The gold standard for continuous BP monitoring in newborns is via arterial line (A-line BP). However, it involves catheterization of the umbilical or a peripheral artery and can lead to complications such as vasospasm, nerve damage, ischemia, thrombosis, and, in severe cases, limb amputation. Due to these risks, A-line BP monitoring is only used when deemed necessary in critically ill neonates.
Existing noninvasive alternatives, including volume-clamp photoplethysmography cuffs, pulse-transit-time, and tonography, are problematic due to large error and safety concerns. They have been validated primarily for adults and are not tailored for neonates who pose unique challenges due to their fragile limbs, underdeveloped vasculature, immature cardiac function, and mean arterial BP often being less than a third of an adult's (30 mmHg).
To address this critical need for accurate, continuous, and noninvasive BP monitoring in newborns, the study team proposes employing a near-infrared spectroscopy (NIRS) technique on the head, focusing on pulsation tones and shapes in cerebral hemodynamics, which are sensitive to BP changes. The team has developed a wearable, battery-operated NIRS device, called FlexNIRS, capable of providing continuous photoplethysmogram (PPG) with a high temporal resolution of 266 Hz. In adults, the team has shown that the time derivative of its optical pulse waveforms d/dt(PPG) is related to pulsatile blood flow, and found strong correlations between specific features of d/dt(NIRS-PPG) and blood pressure changes. Based on these findings, it is hypothesized that NIRS-PPG collected in the brain is most ideal for neonates, especially given their fragile peripheries, and the head site allowing more robust measure of deep brain with less external factors, such as pressure from the sensor itself, room temperature, and extra arterial resistance that builds up in local peripheries. Importantly, the study team has tested the FlexNIRS in a preterm newborn and found pulsatile morphology patterns comparable to those in adults.
The current study aims to validate this novel technique for BP assessment in the newborn population from up to 80 newborns, divided evenly across Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH). Each measurement will involve monitoring infants with one or two FlexNIRS devices for 3-24 hours a day, for at least one day. This data will be used to refine the study team's FlexNIRS-based blood pressure estimation algorithms and correlate results with invasive A-line BP as the gold standard or periodic BP cuff readings performed by clinical staff. This research will provide invaluable data demonstrating method feasibility and initial clinical utility. The successful execution of this aim will guide the study team to a larger clinical study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arterial Line Cohort | – | –We will recruit and measure neonates who are between ≥ 24 weeks and < 44 weeks postmenstrual age, undergoing A-line BP monitoring for clinical reasons. |
| Cuff Cohort | – | –We will recruit and measure neonates in the same age range as in the A-line cohort who are at risk for unstable blood pressure but without A-line BP monitoring, as long as they can tolerate manual cuff-based BP measurements at intervals of at least 1-4 hours. |
Who may qualify
- Ages
- 24 to 44 weeks
- Sex
- All
- Age groups
- Child
- Study population
- The study population will include 80 neonates of ≥24 weeks and <44 weeks postmenstrual age, with or without A-line BP monitoring for clinical reasons. Subjects will be recruited from the Neonatal Intensive Care Unit at MGH and BWH.
Key inclusion criteria (4 listed)
- Neonates ≥24 \& <44 weeks postmenstrual age
- Hospitalization in MGH or BWH newborn service units
- For A-line BP monitoring: Neonates expected to maintain A-line monitoring for at least the next 12 hours
- For non-A-line monitoring: Neonates at risk for unstable blood pressure (e.g. clinical instability or need for inotropes) and no contraindications to manual cuff BP measurements every 1 to 4 hours
Key exclusion criteria (2 listed)
- Contraindication to FlexNIRS device placement on the scalp/head
- Underlying congenital/genetic anomalies
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
FlexNIRS-based blood pressure estimation
Time frame: 04/09/2025 - 11/30/2026
Determine the correlation between FlexNIRS based blood pressure estimation and invasive A-line blood pressure as the gold standard or periodic BP cuff readings performed by clinical staff.
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 3 Jul 2025.
- Background: PubMed 37680339Wu KC, Martin A, Renna M, Robinson M, Ozana N, Carp SA, Franceschini MA. Enhancing diffuse correlation spectroscopy pulsatile cerebral blood flow signal with near-infrared spectroscopy photoplethysmography. Neurophotonics. 2023 Jul;10(3):035008. doi: 10.1117/1.NPh.10.3.035008. Epub 2023 Sep 6.
- Background: PubMed 35452803Wu KC, Tamborini D, Renna M, Peruch A, Huang Y, Martin A, Kaya K, Starkweather Z, Zavriyev AI, Carp SA, Salat DH, Franceschini MA. Open-source FlexNIRS: A low-cost, wireless and wearable cerebral health tracker. Neuroimage. 2022 Aug 1;256:119216. doi: 10.1016/j.neuroimage.2022.119216. Epub 2022 Apr 19.
- Background: PubMed 12953906Boas DA, Strangman G, Culver JP, Hoge RD, Jasdzewski G, Poldrack RA, Rosen BR, Mandeville JB. Can the cerebral metabolic rate of oxygen be estimated with near-infrared spectroscopy? Phys Med Biol. 2003 Aug 7;48(15):2405-18. doi: 10.1088/0031-9155/48/15/311.
- Background: PubMed 20007987Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
- Background: PubMed 36944668Gonzalez S, Hsieh WT, Chen TP. A benchmark for machine-learning based non-invasive blood pressure estimation using photoplethysmogram. Sci Data. 2023 Mar 21;10(1):149. doi: 10.1038/s41597-023-02020-6.
- Background: PubMed 19609309Troy R, Doron M, Laughon M, Tolleson-Rinehart S, Price W. Comparison of noninvasive and central arterial blood pressure measurements in ELBW infants. J Perinatol. 2009 Nov;29(11):744-9. doi: 10.1038/jp.2009.86. Epub 2009 Jul 16.
- Background: PubMed 33566691Dionne JM. Determinants of Blood Pressure in Neonates and Infants: Predictable Variability. Hypertension. 2021 Mar 3;77(3):781-787. doi: 10.1161/HYPERTENSIONAHA.120.14587. Epub 2021 Feb 10.
- Background: PubMed 37050750Rao A, Eskandar-Afshari F, Weiner Y, Billman E, McMillin A, Sella N, Roxlo T, Liu J, Leong W, Helfenbein E, Walendowski A, Muir A, Joseph A, Verma A, Ramamoorthy C, Honkanen A, Green G, Drake K, Govindan RB, Rhine W, Quan X. Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates. Sensors (Basel). 2023 Apr 2;23(7):3690. doi: 10.3390/s23073690.
- Background: PubMed 31771082Alonzo CJ, Nagraj VP, Zschaebitz JV, Lake DE, Moorman JR, Spaeder MC. Blood pressure ranges via non-invasive and invasive monitoring techniques in premature neonates using high resolution physiologic data. J Neonatal Perinatal Med. 2020;13(3):351-358. doi: 10.3233/NPM-190260.
- Background: PubMed 3451967Lynch TM. Invasive and noninvasive pressure monitoring in neonates. J Perinat Neonatal Nurs. 1987 Jul;1(1):58-71. doi: 10.1097/00005237-198707000-00010. No abstract available.
- Background: PubMed 23700412Hahn GH, Hyttel-Sorensen S, Petersen SM, Pryds O, Greisen G. Cerebral effects of commonly used vasopressor-inotropes: a study in newborn piglets. PLoS One. 2013 May 20;8(5):e63069. doi: 10.1371/journal.pone.0063069. Print 2013.
- Background: PubMed 21813560Turner MA, Baines P. Which inotrope and when in neonatal and paediatric intensive care? Arch Dis Child Educ Pract Ed. 2011 Dec;96(6):216-22. doi: 10.1136/adc.2008.143925. Epub 2011 Aug 3. No abstract available.
- Individual participant dataSharing planned: Yes. Coded and deidentified data may be shared with collaborators outside of Mass General Brigham. All external data sharing will be tracked and logged, and upon request, this information will be readily available to the subjects. The PI will supervise daily lab/team data management and sharing activities, ensuring strict adherence to the data sharing policies outlined by MGB. No identifiable data will be shared or received from collaborators outside of Mass General Brigham.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Blood Pressure and Hypotension, run by Massachusetts General Hospital at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Emily M Herzberg, MD (617 724 9040, eherzberg@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FlexNIRS-based blood pressure estimation (time frame: 04/09/2025 - 11/30/2026). 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 NCT06994494, which also lists 15 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 3 Jul 2025.