Intraoperative Hypotension in High-risk Patients Undergoing Surgery

NCT05884918 | Unknown

• 1 other identifier: 1/2023
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Hypotension on Induction; Perioperative Injury; Perioperative Hypotension

Outcome Measures

Primary Outcomes (2)

• Incidence of intraoperative hypotension (IOH)

  Incidence of IOH due to the general anesthesia

  Intraoperative

• Risk factors of IOH.

  Rate of specific clinical and demographical parameters associated with IOH

  Perioperative

Secondary Outcomes (5)

• Development of a risk scale for IOH (MAP < 65mmHg) based on the identified risk factors in the study.

  Perioperative

• Determination of indications for intraoperative extended hemodynamic monitoring.

  Perioperative

• Assessment of the incidence, duration, and depth of hypotension as a complication of general anesthesia at each stage of anesthesia.

  Perioperative

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Age: \> 18 years old. Gender: Women and men. Preoperative qualification for advanced hemodynamic monitoring based on the estimated high risk of postoperative complications.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mazovia Regional Hospital in Siedlce: lead

Study Sites (1)

Mazovian Regional Hospital

Siedlce, Mazovian, 08110, Poland

RECRUITING

Study Officials

• Jolanta Cylwik, PhD

  Mazovian Regional Hospital in Siedlce, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolanta Cylwik, PhD

CONTACT

0048602859457; Jolacylwik@o2.pl

Malgorzata Celinska-Spodar

CONTACT

0048603710608; Mcelinska@ikard.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 1, 2023
• Study Start: March 2, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 31, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

PL (1)