AnesthesiaIRIoHYPNCT05884918
Intraoperative Hypotension in High-risk Patients Undergoing Surgery
An observational study of Anesthesia and Hypotension on Induction, run by Mazovia Regional Hospital in Siedlce at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Hypotension on Induction, Perioperative Injury
- How many people
- 2,000 participants
- Where
- 1 sitePoland
- Study dates
- 2 Mar 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Mazovian Regional Hospital
Siedlce, Mazovian, 08110
Jolanta Cylwik, PhD, 0048602859457, Jolacylwik@o2.pl
Malgorzata Celinska-Spodar, 0048603710608, Mcelinska@ikard.pl
About this study
Official title: Risk Factors and Frequency of Intraoperative Hypotension in High-risk Patients Undergoing Surgery: A Multicenter Observational Prospective Study
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:
Read more
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypotension (IOH)
Incidence of IOH due to the general anesthesia
Measured: Intraoperative
Risk factors of IOH.
Rate of specific clinical and demographical parameters associated with IOH
Measured: Perioperative
Secondary outcomes (5)
Development of a risk scale for IOH (MAP < 65mmHg) based on the identified risk factors in the study.
Combination of the most significant risk factors of IOH into risk scale.
Measured: Perioperative
Determination of indications for intraoperative extended hemodynamic monitoring.
List of pre-operative clinical factors indicating elevated risk of peri-operative complications
Measured: Perioperative
Assessment of the incidence, duration, and depth of hypotension as a complication of general anesthesia at each stage of anesthesia.
List of specific parameters related to IOH.
Measured: 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.
List of clinical factors associated with IOH impacting clinical adverse events during 30 days follow up.
Measured: 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.
List of routine actions triggered by the IOH in the anesthesiological management.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start2 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mazovia Regional Hospital in Siedlce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Cylwik, Mazovia Regional Hospital in Siedlce
- Investigators
- Jolanta Cylwik, PhD, Principal investigator, Mazovian Regional Hospital in Siedlce, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884918
- Sponsor's protocol ID
- 1/2023
- Acronym
- IRIoHYP
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Frequency of Intraoperative Hypotension in High-risk Patients Undergoing Surgery: A Multicenter Observational Prospective Study
- ClinicalTrials.gov ID
- NCT05884918
- Acronym / sponsor ID
- IRIoHYP / 1/2023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mazovia Regional Hospital in SiedlceUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- Age <18 years old.
- Cardiac surgeries.
- Thoracic surgeries.
- Obstetric procedures.
- Inability of the patient to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of intraoperative hypotension (IOH)
Time frame: Intraoperative
Incidence of IOH due to the general anesthesia
Risk factors of IOH.
Time frame: Perioperative
Rate of specific clinical and demographical parameters associated with IOH
5 secondary outcomes
Development of a risk scale for IOH (MAP < 65mmHg) based on the identified risk factors in the study.
Time frame: Perioperative
Determination of indications for intraoperative extended hemodynamic monitoring.
Time frame: Perioperative
Assessment of the incidence, duration, and depth of hypotension as a complication of general anesthesia at each stage of anesthesia.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta Cylwik, PhD principal investigator
Mazovian Regional Hospital in Siedlce, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Hypotension on Induction, run by Mazovia Regional Hospital in Siedlce at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jolanta Cylwik, PhD (0048602859457, Jolacylwik@o2.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hypotension (IOH) (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.