Spinal HypotensionNCT07534774
Pilot Study of Real-Time Blood Pressure Decision Support During Cesarean Delivery Under Spinal Anesthesia
A study testing ARX Decision-Support Display in people with Spinal Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This single-center, open-label pilot study evaluates a clinician-facing decision-support algorithm that displays real-time forecasts of maternal mean arterial pressure (MAP), a measure of blood pressure, during elective cesarean delivery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Spinal Hypotension
- What is being tested?
- ARX Decision-Support Display
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 16 Jul 2025
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult pregnant individuals (≥18 years old) presenting for elective or scheduled cesarean delivery.
- ASA physical status 2 or 3 (obstetric patients without severe comorbidities).
- Singleton pregnancy at term (≥37 weeks gestation).
- Planned spinal anesthesia for cesarean delivery with phenylephrine infusion (and/or boluses) as the primary vasopressor.
- Able to provide informed consent.
- No known fetal anomalies or intrauterine demise.
Who cannot join
- Pre-existing or gestational hypertensive disorders (e.g., chronic hypertension, preeclampsia, eclampsia) or use of cardiovascular medications that can affect blood pressure or heart rate (e.g.
- propranolol for migraine)
- Known major cardiovascular disease or arrhythmias requiring treatment (e.g., heart failure, significant valvular disease).
- Planned use of non-phenylephrine vasopressors (e.g., ephedrine, norepinephrine) for routine BP management.
- Allergy or contraindication to bupivacaine or phenylephrine.
- Urgent or emergent cesarean delivery (where time constraints may not allow for adequate data collection or informed consent).
- Inability to cooperate with protocol procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Open-Label Pilot Study of a Clinician-Facing Decision-Support Algorithm for Blood Pressure Forecasting During Cesarean Delivery Under Spinal Anesthesia
This single-center, open-label pilot study evaluates a clinician-facing decision-support algorithm that displays real-time forecasts of maternal mean arterial pressure (MAP), a measure of blood pressure, during elective cesarean delivery under spinal anesthesia. The display provides 1-, 2-, and 3-minute MAP forecasts from the time of spinal anesthesia administration until delivery or up to 20 minutes, whichever occurs first. Clinicians continue to manage blood pressure according to usual institutional practice, including phenylephrine infusion and bolus dosing, and retain full autonomy over treatment decisions; the study display does not provide dosing recommendations. The primary objective is to assess the prospective accuracy of short-horizon MAP forecasts. Secondary outcomes assess intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls.
Read the detailed description
This single-center, open-label, single-group pilot study evaluated the prospective performance and operating-room feasibility of a clinician-facing autoregressive with exogenous input (ARX) decision-support algorithm for short-horizon maternal blood pressure forecasting during elective cesarean delivery under spinal anesthesia. Adult pregnant patients at term undergoing elective cesarean delivery with planned spinal anesthesia and prophylactic phenylephrine management were enrolled at a tertiary care academic hospital.
The ARX system generated real-time forecasts of maternal mean arterial pressure (MAP) at 1-, 2-, and 3-minute horizons from the time of spinal anesthesia administration until delivery or 20 minutes, whichever occurred first. The model used prior MAP values together with time-stamped phenylephrine infusion and bolus dosing and intrathecal bupivacaine dose/time as inputs. Forecasts were displayed on a dedicated screen adjacent to the anesthesia workstation. The display was intended to support clinician awareness of short-horizon hemodynamic trends and did not provide dosing recommendations. Blood pressure management remained under usual clinical care, including phenylephrine infusion and bolus administration according to institutional practice, and treating anesthesiologists retained full autonomy over all management decisions.
The primary objective was to assess prospective forecast accuracy at each prediction horizon using the difference between predicted and observed MAP during the study observation window. Additional analyses assessed other forecast-accuracy metrics, short-horizon identification of hypotension defined as MAP below 80% of baseline, and implementation feasibility based on uninterrupted display operation and clinician-reported overrides. Baseline MAP was defined as the mean of the last three pre-spinal noninvasive blood pressure measurements. Baseline MAP was defined as the mean of the last three pre-spinal noninvasive blood pressure measurements. Noninvasive blood pressure was recorded at 1-minute intervals, and model inputs were entered in real time by in-room research staff. Secondary outcomes assessed intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls; these analyses were not part of prospective assignment to the study intervention.
- Conditions
- Spinal Hypotension
- Being tested
- ARX Decision-Support Display
- Keywords
- cesarean delivery, phenylephrine, autoregressive with exogenous input, decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARX Decision-Support DisplayOther
A clinician-facing decision-support display that presented real-time 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure during elective cesarean delivery under spinal anesthesia, from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice
| Study group | Role | What they receive |
|---|---|---|
| ARX Decision-Support Display | Experimental | Participants undergoing elective cesarean delivery under spinal anesthesia received standard clinical management plus a clinician-facing ARX decision-support display that showed 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice. Receives: Other: ARX Decision-Support Display |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast
Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 1-minute forecast horizon using minute-level intraoperative data.
Measured: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Root Mean Square Error of 2-Minute-Ahead Mean Arterial Pressure Forecast
Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 2-minute forecast horizon using minute-level intraoperative data.
Measured: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Root Mean Square Error of 3-Minute-Ahead Mean Arterial Pressure Forecast
Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 3-minute forecast horizon using minute-level intraoperative data.
Measured: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Secondary outcomes (3)
Incidence of Maternal Hypotension During the Observation Window
Presence of at least one maternal mean arterial pressure measurement below 80% of baseline during the observation window; exploratory comparison with matched nonconcurrent controls.
Measured: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Duration of Maternal Hypotension During the Observation Window
Cumulative minutes with maternal mean arterial pressure below 80% of baseline during the observation window; exploratory comparison with matched nonconcurrent controls.
Measured: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Total Phenylephrine Dose During the Observation Window
Total phenylephrine dose calculated as the sum of all bolus doses plus infusion dose integrated over time during the observation window; exploratory comparison with matched nonconcurrent controls.
Measured: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start16 Jun 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women'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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesela Kovacheva, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534774
- Sponsor's protocol ID
- 2025P000588
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pilot Study of a Clinician-Facing Decision-Support Algorithm for Blood Pressure Forecasting During Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07534774
- Acronym / sponsor ID
- 2025P000588
- Conditions
- Spinal Hypotension
- Keywords
- cesarean delivery, phenylephrine, autoregressive with exogenous input, decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 16 Apr 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 single-center, open-label pilot study evaluates a clinician-facing decision-support algorithm that displays real-time forecasts of maternal mean arterial pressure (MAP), a measure of blood pressure, during elective cesarean delivery under spinal anesthesia. The display provides 1-, 2-, and 3-minute MAP forecasts from the time of spinal anesthesia administration until delivery or up to 20 minutes, whichever occurs first. Clinicians continue to manage blood pressure according to usual institutional practice, including phenylephrine infusion and bolus dosing, and retain full autonomy over treatment decisions; the study display does not provide dosing recommendations. The primary objective is to assess the prospective accuracy of short-horizon MAP forecasts. Secondary outcomes assess intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls.
Detailed description
This single-center, open-label, single-group pilot study evaluated the prospective performance and operating-room feasibility of a clinician-facing autoregressive with exogenous input (ARX) decision-support algorithm for short-horizon maternal blood pressure forecasting during elective cesarean delivery under spinal anesthesia. Adult pregnant patients at term undergoing elective cesarean delivery with planned spinal anesthesia and prophylactic phenylephrine management were enrolled at a tertiary care academic hospital.
The ARX system generated real-time forecasts of maternal mean arterial pressure (MAP) at 1-, 2-, and 3-minute horizons from the time of spinal anesthesia administration until delivery or 20 minutes, whichever occurred first. The model used prior MAP values together with time-stamped phenylephrine infusion and bolus dosing and intrathecal bupivacaine dose/time as inputs. Forecasts were displayed on a dedicated screen adjacent to the anesthesia workstation. The display was intended to support clinician awareness of short-horizon hemodynamic trends and did not provide dosing recommendations. Blood pressure management remained under usual clinical care, including phenylephrine infusion and bolus administration according to institutional practice, and treating anesthesiologists retained full autonomy over all management decisions.
The primary objective was to assess prospective forecast accuracy at each prediction horizon using the difference between predicted and observed MAP during the study observation window. Additional analyses assessed other forecast-accuracy metrics, short-horizon identification of hypotension defined as MAP below 80% of baseline, and implementation feasibility based on uninterrupted display operation and clinician-reported overrides. Baseline MAP was defined as the mean of the last three pre-spinal noninvasive blood pressure measurements. Baseline MAP was defined as the mean of the last three pre-spinal noninvasive blood pressure measurements. Noninvasive blood pressure was recorded at 1-minute intervals, and model inputs were entered in real time by in-room research staff. Secondary outcomes assessed intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls; these analyses were not part of prospective assignment to the study intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARX Decision-Support Display | Experimental | Other: ARX Decision-Support DisplayParticipants undergoing elective cesarean delivery under spinal anesthesia received standard clinical management plus a clinician-facing ARX decision-support display that showed 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult pregnant individuals (≥18 years old) presenting for elective or scheduled cesarean delivery.
- ASA physical status 2 or 3 (obstetric patients without severe comorbidities).
- Singleton pregnancy at term (≥37 weeks gestation).
- Planned spinal anesthesia for cesarean delivery with phenylephrine infusion (and/or boluses) as the primary vasopressor.
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- Pre-existing or gestational hypertensive disorders (e.g., chronic hypertension, preeclampsia, eclampsia) or use of cardiovascular medications that can affect blood pressure or heart rate (e.g.
- propranolol for migraine)
- Known major cardiovascular disease or arrhythmias requiring treatment (e.g., heart failure, significant valvular disease).
- Planned use of non-phenylephrine vasopressors (e.g., ephedrine, norepinephrine) for routine BP management.
- Allergy or contraindication to bupivacaine or phenylephrine.
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 |
|---|---|---|
| ARX Decision-Support DisplayA clinician-facing decision-support display that presented real-time 1-, 2-, and 3-minute forecasts of maternal mean arterial pressure during elective cesarean delivery under spinal anesthesia, from spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first. The display did not provide dosing recommendations. Phenylephrine infusion and bolus dosing remained under clinician direction according to institutional practice | Other | ARX Decision-Support Display |
Primary outcome
Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast
Time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 1-minute forecast horizon using minute-level intraoperative data.
Root Mean Square Error of 2-Minute-Ahead Mean Arterial Pressure Forecast
Time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 2-minute forecast horizon using minute-level intraoperative data.
Root Mean Square Error of 3-Minute-Ahead Mean Arterial Pressure Forecast
Time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Patient-level mean root mean square error (RMSE) between algorithm-predicted and observed maternal mean arterial pressure (MAP) for the 3-minute forecast horizon using minute-level intraoperative data.
3 secondary outcomes
Incidence of Maternal Hypotension During the Observation Window
Time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Duration of Maternal Hypotension During the Observation Window
Time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
Total Phenylephrine Dose During the Observation Window
Time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.
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 16 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARX Decision-Support Display in people with Spinal Hypotension, run by Brigham and Women'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 6 inclusion and 7 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 16 Apr 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?
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?
Root Mean Square Error of 1-Minute-Ahead Mean Arterial Pressure Forecast (time frame: From spinal anesthesia administration until delivery or up to 20 minutes, whichever occurred first.). The study lists 3 primary outcomes in all. 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 16 Apr 2026.