Intraoperative HypotensionNCT07840937
Feasibility Study of E-Fusion Vasopressor Titration-Assist During Multi-Level Spine Surgery
A study testing E-Fusion Vasopressor Titration-Assist in people with Intraoperative Hypotension, run by Autonomous Healthcare, Inc. at 1 site in United States.
Trial summary
This is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery. E-Fusion monitors blood pressure from the patient monitor and displays recommended changes to the norepinephrine infusion rate. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- E-Fusion Vasopressor Titration-Assist
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Aug 2027
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 years or older
- Patient or a legally authorized representative (LAR) has provided written informed consent
- Patient is expected to receive norepinephrine through a central line, PICC line, or peripheral line for blood pressure management
- Patient's blood pressure is monitored with an arterial line
- Patient is undergoing multi-level spine surgery with an expected duration of at least 2 hours and not exceeding 8 hours
Who cannot join
- Confirmed pregnancy and/or nursing mothers
- Currently participating in another interventional study
- Patients who are likely to bleed excessively and/or need rapid transfusion
- Patients expected to be disconnected and transported for imaging during the study procedure
- History of cardiac arrhythmias
- Patients receiving another actively titrated vasopressor during study (excluding vasopressin)
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
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Feasibility Study of E-Fusion Vasopressor Titration-Assist as a Clinical Decision Support Tool During Multi-Level Spine Surgery
This is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery. E-Fusion monitors blood pressure from the patient monitor and displays recommended changes to the norepinephrine infusion rate. The anesthesia provider independently reviews each recommendation and may accept or ignore it. The software does not connect to or control the infusion pump. The primary objective is to assess safety by evaluating adverse events attributable to E-Fusion during surgery. Secondary objectives evaluate clinician agreement with the recommendations and blood pressure management.
- Conditions
- Intraoperative Hypotension
- Being tested
- E-Fusion Vasopressor Titration-Assist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Fusion Vasopressor Titration-AssistDevice
Clinical decision support software that monitors mean arterial pressure from the patient monitor and displays recommended norepinephrine infusion rate changes. The clinician independently evaluates each recommendation and makes all infusion rate changes manually. The software does not connect to or control the infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| E-Fusion clinical decision support | Experimental | All subjects receive standard anesthetic care. E-Fusion displays advisory norepinephrine infusion rate recommendations that the anesthesia provider may accept or ignore. Receives: Device: E-Fusion Vasopressor Titration-Assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events and serious adverse events of relevance attributed to E-Fusion
Number of adverse events (AEs) and serious adverse events (SAEs) of relevance occurring during surgery, attributed to E-Fusion based on clinician assessment, including major adverse cardiac events, intraoperative arrhythmia, and infusion-related injury.
Measured: Intraoperative period, from E-Fusion activation to deactivation or end of surgery, up to 8 hours
Secondary outcomes (2)
Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider
Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider after their independent review.
Measured: Intraoperative period, up to 8 hours
Time-weighted average mean arterial pressure (TWA-MAP) above and below target
Time-weighted average MAP above and below the clinician-set target, stratified by compliance group: high (greater than 80%), medium (50-80%), and low (less than 50%) compliance with E-Fusion recommendations.
Measured: Intraoperative period, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startMar 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autonomous Healthcare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ashish Khanna, MD, Principal investigator, Wake Forest University Health SciencesBehnood Gholami, PhD, Study director, Autonomous Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840937
- Sponsor's protocol ID
- EF-SPINE-001
- Other IDs
- 1R43HL187059-01
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of E-Fusion Vasopressor Titration-Assist as a Clinical Decision Support Tool During Multi-Level Spine Surgery
- ClinicalTrials.gov ID
- NCT07840937
- Acronym / sponsor ID
- EF-SPINE-001
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Autonomous Healthcare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Sep 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 is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery. E-Fusion monitors blood pressure from the patient monitor and displays recommended changes to the norepinephrine infusion rate. The anesthesia provider independently reviews each recommendation and may accept or ignore it. The software does not connect to or control the infusion pump. The primary objective is to assess safety by evaluating adverse events attributable to E-Fusion during surgery. Secondary objectives evaluate clinician agreement with the recommendations and blood pressure management.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Fusion clinical decision support | Experimental | Device: E-Fusion Vasopressor Titration-AssistAll subjects receive standard anesthetic care. E-Fusion displays advisory norepinephrine infusion rate recommendations that the anesthesia provider may accept or ignore. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 22 years or older
- Patient or a legally authorized representative (LAR) has provided written informed consent
- Patient is expected to receive norepinephrine through a central line, PICC line, or peripheral line for blood pressure management
- Patient's blood pressure is monitored with an arterial line
- Patient is undergoing multi-level spine surgery with an expected duration of at least 2 hours and not exceeding 8 hours
Key exclusion criteria (6 listed)
- Confirmed pregnancy and/or nursing mothers
- Currently participating in another interventional study
- Patients who are likely to bleed excessively and/or need rapid transfusion
- Patients expected to be disconnected and transported for imaging during the study procedure
- History of cardiac arrhythmias
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 |
|---|---|---|
| E-Fusion Vasopressor Titration-AssistClinical decision support software that monitors mean arterial pressure from the patient monitor and displays recommended norepinephrine infusion rate changes. The clinician independently evaluates each recommendation and makes all infusion rate changes manually. The software does not connect to or control the infusion pump. | Device | E-Fusion clinical decision support |
Primary outcome
Number of adverse events and serious adverse events of relevance attributed to E-Fusion
Time frame: Intraoperative period, from E-Fusion activation to deactivation or end of surgery, up to 8 hours
Number of adverse events (AEs) and serious adverse events (SAEs) of relevance occurring during surgery, attributed to E-Fusion based on clinician assessment, including major adverse cardiac events, intraoperative arrhythmia, and infusion-related injury.
2 secondary outcomes
Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider
Time frame: Intraoperative period, up to 8 hours
Time-weighted average mean arterial pressure (TWA-MAP) above and below target
Time frame: Intraoperative period, up to 8 hours
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 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Intraoperative Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruiting
Applying HPI in Oral Cancer Surgery
the Severity and Duration of Intraoperative Hypotension
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
Not yet recruitingObservational study
Intelligent Classification of Intraoperative Hemodynamic Phenotypes Based on CADFlow Doppler Monitoring
Ultrasound, Machine Learning
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.
Ashish Khanna, MD principal investigator
Wake Forest University Health Sciences
Behnood Gholami, PhD study director
Autonomous Healthcare, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Fusion Vasopressor Titration-Assist in people with Intraoperative Hypotension, run by Autonomous Healthcare, Inc. 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 5 inclusion and 6 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 25 Sep 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 Behnood Gholami, PhD (347-774-1617, info@autonomoushealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events and serious adverse events of relevance attributed to E-Fusion (time frame: Intraoperative period, from E-Fusion activation to deactivation or end of surgery, up to 8 hours). 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 25 Sep 2026.