AI-supported non-invasive measurement for intraoperative hypotension reduction in major Orthopedic and trauma surgery—study protocol for a randomized clinical trial Article Swipe
Marit Habicher
,
Rosa Kleymann
,
Karim Shakkour
,
N Holstein
,
Christian Koch
,
Melanie Markmann
,
Emmanuel Schneck
,
Michael Sander
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1186/s13063-025-09194-x
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1186/s13063-025-09194-x
Background Intraoperative 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/design This 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. Conclusion This 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 registration ClinicalTrials.gov NCT06291714. Registered on 4 March 2024.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s13063-025-09194-x
- https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-025-09194-x
- OA Status
- gold
- References
- 22
- OpenAlex ID
- https://openalex.org/W4415696954
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4415696954Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1186/s13063-025-09194-xDigital Object Identifier
- Title
-
AI-supported non-invasive measurement for intraoperative hypotension reduction in major Orthopedic and trauma surgery—study protocol for a randomized clinical trialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-10-30Full publication date if available
- Authors
-
Marit Habicher, Rosa Kleymann, Karim Shakkour, N Holstein, Christian Koch, Melanie Markmann, Emmanuel Schneck, Michael SanderList of authors in order
- Landing page
-
https://doi.org/10.1186/s13063-025-09194-xPublisher landing page
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https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-025-09194-xDirect link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-025-09194-xDirect OA link when available
- Cited by
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0Total citation count in OpenAlex
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| abstract_inverted_index.NCT06291714. | 317 |
| abstract_inverted_index.Participants | 126 |
| abstract_inverted_index.complication | 8 |
| abstract_inverted_index.intervention | 134 |
| abstract_inverted_index.investigates | 56 |
| abstract_inverted_index.measurement, | 48 |
| abstract_inverted_index.monocentric, | 97 |
| abstract_inverted_index.non-invasive | 36, 306 |
| abstract_inverted_index.registration | 315 |
| abstract_inverted_index.comparability | 180 |
| abstract_inverted_index.complications | 88 |
| abstract_inverted_index.discontinuous | 47 |
| abstract_inverted_index.non-invasive, | 61 |
| abstract_inverted_index.postoperative | 16, 31, 238, 252, 298 |
| abstract_inverted_index.time-weighted | 224 |
| abstract_inverted_index.Intraoperative | 2 |
| abstract_inverted_index.Methods/design | 95 |
| abstract_inverted_index.complications, | 299 |
| abstract_inverted_index.interventional | 100 |
| abstract_inverted_index.intraoperative | 285 |
| abstract_inverted_index.high-sensitivity | 247 |
| abstract_inverted_index.anesthesiologist, | 176 |
| abstract_inverted_index.ClinicalTrials.gov | 316 |
| cited_by_percentile_year | |
| corresponding_author_ids | https://openalex.org/A5055829605 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 8 |
| corresponding_institution_ids | https://openalex.org/I200763008, https://openalex.org/I268975460 |
| citation_normalized_percentile |