Intraoperative Hypotension in High-risk Patients Undergoing Surgery

Recruiting

• Conditions: Perioperative Injury; Anesthesia; Hypotension on Induction; Perioperative Hypotension

• Registration Number: NCT05884918
• Lead Sponsor: Mazovia Regional Hospital in Siedlce

Brief Summary

The primary objective of this observational study is to investigate the risk factors for intraoperative hypotension and identify the underlying pathomechanisms leading to it, both during the period after general anesthesia induction and throughout its course.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Status Verified: 2023-05
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age >18 years old.
• 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

• Age <18 years old.
• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hypotension (IOH)	Intraoperative	Incidence of IOH due to the general anesthesia
Risk factors of IOH.	Perioperative	Rate of specific clinical and demographical parameters associated with IOH

Secondary Outcome Measures

Name	Time	Method
Determination of indications for intraoperative extended hemodynamic monitoring.	Perioperative	List of pre-operative clinical factors indicating elevated risk of peri-operative complications
Development of a risk scale for IOH (MAP < 65mmHg) based on the identified risk factors in the study.	Perioperative	Combination of the most significant risk factors of IOH into risk scale.
Assessment of the incidence, duration, and depth of hypotension as a complication of general anesthesia at each stage of anesthesia.	Perioperative	List of specific parameters related to IOH.
Evaluation of the relationship between the depth and duration of hypotensive episodes and the occurrence of postoperative complications within 30 days of the surgical procedure.	Perioperative to 30 days after surgery	List of clinical factors associated with IOH impacting clinical adverse events during 30 days follow up.
Analysis of the anesthesiologist's management approach in the event of hypotensive episodes or hypotension risks and an attempt to establish an optimal management strategy for its occurrence.	Perioperative	List of routine actions triggered by the IOH in the anesthesiological management.

Trial Locations

Locations (1)

Mazovian Regional Hospital; 🇵🇱 Siedlce, Mazovian, Poland