Evidence map›Paper›PMID 41168839›Full record

ArticleTrials2025

AI-supported non-invasive measurement for intraoperative hypotension reduction in major Orthopedic and trauma surgery-study protocol for a randomized clinical trial.

Marit Habicher, Rosa Kleymann, Karim Shakkour, Nuria Holstein, Christian Koch, Melanie Markmann, Emmanuel Schneck, Michael Sander

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06291714 (Prospective Interventional Study Investigating a Goal-directed Therapy Based on Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Hypotension in Patients Undergoing Major Orthopedic and Trauma Surgery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06291714 narecruitingnot on this map

Prospective Interventional Study Investigating a Goal-directed Therapy Based on Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Hypotension in Patients Undergoing Major Orthopedic and Trauma Surgery

TypeinterventionalSponsorUniversity of GiessenRan2024 to 2026Enrolled150ConditionsIntraoperative Hypotension, Acute Kidney Injury, Myocardial Injury After Non-cardiac SurgeryArmsGDT-based hemodynamic management based on Clearsight device
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Marit HabicherDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany. Marit.Habicher@chiru.med.uni-giessen.de.ORCID http://orcid.org/0000-0001-8964-3819
Rosa KleymannDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.
Karim ShakkourDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.
Nuria HolsteinDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.
Christian KochDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.
Melanie MarkmannDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.
Emmanuel Schneck *Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.
Michael Sander *Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, University Hospital of Giessen & Marburg, Rudolf-Buchheim-Street 7, Giessen, 35392, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntraoperative hypotension (IOH) is a common complication in non-cardiac surgeries, with significant impacts on postoperative outcomes such as acute kidney injury (AKI), myocardial injury after non-cardiac surgery (MINS), and postoperative cognitive dysfunction (delirium). Traditional non-invasive blood pressure monitoring often results in blind gaps through the discontinuous measurement, potentially missing critical hypotensive events. This study investigates the efficacy of a non-invasive, continuous AI-supported technology using the Hypotension Prediction Index (HPI) system, designed to predict and mitigate IOH, in reducing the incidence and severity of IOH and related complications in major orthopedic and trauma surgeries. METHODS/

designThis monocentric, randomized, prospective interventional trial will be conducted at the University Hospital Giessen. The study will include patients aged 45 years and older undergoing major orthopedic or trauma surgeries. Participants will be randomized into two groups: an intervention group receiving hemodynamic management using the ClearSight system in combination with a HPI-based treatment algorithm and a control group receiving standard care. The patients from the standard group also receive continuous cardiac output monitoring; however, this will be blinded to the anesthesiologist, to ensure the comparability of the measured hemodynamic parameters. The primary endpoint is the incidence, duration and severity of IOH, which is defined as MAP < 65 mmHg for at least one minute and which is calculated as the area under MAP < 65 mmHg and the time-weighted average (TWA) of MAP < 65 mmHg. Secondary endpoints include the occurrence of postoperative AKI (measured by KDIGO criteria), MINS (measured by high-sensitivity troponin I assays), and postoperative delirium. The study aims to recruit 150 patients, accounting for potential dropouts, to provide sufficient power to detect differences in the primary and secondary endpoints.

conclusionThis study aims to demonstrate improved intraoperative hemodynamic stability, with a reduction of hypotension and a reduced incidence of postoperative complications, potentially setting a new standard for non-invasive continuous monitoring in orthopedic and trauma patients.

trial registrationClinicalTrials.gov NCT06291714. Registered on 4 March 2024.

Indexed as

HypotensionIntraoperative ComplicationsMonitoring, IntraoperativeOrthopedic ProceduresWounds and InjuriesAcute Care SurgeryAgedFemaleHumansMaleMiddle AgedPredictive Value of TestsProspective StudiesRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeAcute kidney injuryAIClearSight HPI systemIntraoperative hypotensionMajor orthopedic surgeryMyocardial injuryNon-invasive monitoringTrauma surgery

Identifiers

PMID41168839
PMCPMC12577059

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.