Intraoperative Hypotension in High-risk Patients Undergoing Surgery
NCT ID: NCT05884918
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2023-03-02
2025-01-31
Brief Summary
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The main questions it aims to answer are:
* how frequent is intraoperative hypotension
* what are the underlying pathomechanism causing it The study is including patients who have been identified as having a high risk of perioperative complications (ASA3 or ASA4). Patients included in the study undergo advanced hemodynamic monitoring during the procedure. Anesthesia induction, maintenance, and termination are conducted by an anesthesiologist in accordance with current medical knowledge, and the planned experiment does not in any way influence the course of action.
Investigators will analyse medical documentation, including the patient's medical history, anesthesia records, and hemodynamic parameter data obtained from the hemodynamic monitor (an Excel file containing comprehensive data related to specific cardiovascular parameters) to describe the incidence of intraoperative hypotension and answer key questions in accordance with the designed study protocol.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Capability of providing informed consent by the patient.
* Planned surgeries.
* Surgeries other than thoracic, cardiac, or obstetric procedures.
* ASA (American Society of Anesthesiologists) physical status classification of 3 or 4, indicating high risk.
* Patients at high risk of postoperative complications.
* Preoperative qualification for advanced hemodynamic monitoring.
* Access to complete preoperative health status data.
* Access to complete data regarding the course of anesthesia and hemodynamic parameters obtained from the hemodynamic monitoring platform.
* Initiation of hemodynamic monitoring prior to general anesthesia induction.
Exclusion Criteria
* Cardiac surgeries.
* Thoracic surgeries.
* Obstetric procedures.
* Inability of the patient to provide informed consent.
* ASA physical status classification of 1, 2, or 5, indicating low or moderate risk.
* Urgent and emergent surgeries.
* Lack of complete preoperative health status data.
* Lack of complete data regarding the course of anesthesia.
* Inability to initiate hemodynamic monitoring prior to general anesthesia induction.
* Interruption in hemodynamic monitoring lasting longer than 5 minutes (lack of parameter values in the obtained hemodynamic monitor file).
18 Years
ALL
No
Sponsors
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Mazovia Regional Hospital in Siedlce
OTHER
Responsible Party
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Jolanta Cylwik
Principal Investigator
Principal Investigators
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Jolanta Cylwik, PhD
Role: PRINCIPAL_INVESTIGATOR
Mazovian Regional Hospital in Siedlce, Poland
Locations
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Mazovian Regional Hospital
Siedlce, Mazovian, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1/2023
Identifier Type: -
Identifier Source: org_study_id
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