Predicting low blood pressure during lung surgery
An Observational, Prospective, Non-randomized Multi-centre Cohort Feasibility Study of the Hypotension Prediction Index (HPI) in Patients Undergoing Lung Resections With the Use of One-lung Ventilation.
This study is testing a new tool that uses machine learning to predict low blood pressure during lung surgery to help keep patients safer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 3 sites (Athens and 2 other locations) |
| Trial ID | NCT06202638 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Hypotension Prediction Index (HPI), an algorithm that uses machine learning to predict intraoperative hypotension by analyzing arterial pressure waveforms. The study will involve patients undergoing lung resection procedures with one-lung ventilation, focusing on those who require invasive blood pressure monitoring. By continuously assessing various hemodynamic parameters, the HPI seeks to identify early signs of hypotension, potentially improving patient outcomes during surgery.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with ASA physical status II to IV scheduled for lung resection surgeries requiring invasive blood pressure monitoring.
Not a fit: Patients undergoing urgent or emergency procedures, or those with significant cardiac conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of blood pressure during lung surgeries, reducing the risk of complications.
How similar studies have performed: While the HPI has been validated in other surgical populations, its application in thoracic surgery with one-lung ventilation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status II to IV; * Planned invasive blood pressure monitoring during general anesthesia expected to last more than 2 hours and planned overnight hospitalization. * Procedures: video-assist thoracoscopic (VATS)-lobectomy, open-thoracotomy lobectomy, pneumonectomy. * Adults over 18 years old. Exclusion Criteria: * Urgent/emergency procedures. * Patients with known clinically important intracardiac shunts. * Moderate to severe valvular disease. * Preoperative symptomatic arrhythmias including AF. * Congestive heart failure with LV ejection fraction less than 35%. * Refusal of participation
Where this trial is running
Athens and 2 other locations
- Faculty of Medicine, NKUA Attikon University Hospital — Athens, Greece (Not_yet_recruiting)
- St. John Paul II Hospital in Krakow — Krakow, Małopolska, Poland (Recruiting)
- Department of Anesthesiology and Intensive Therapy; Department of Pain Research and Treatment, Faculty of Medical Sciences Zabrze — Zabrze, Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Mirosław Ziętkiewicz, MD, PhD — 2nd Anesthesiology and Intensive Care Unit, John Paul II Hospital, Prądnicka St. 80, Kraków, Poland
- Study coordinator: Mirosław Ziętkiewicz, MD, PhD
- Email: mjzietkiewicz@gmail.com
- Phone: +48 609 668 145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.