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RecruitingNCT06202638

Hypotension Prediction Index (HPI) in Lung Resections

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.

Sponsor

John Paul II Hospital, Krakow

Enrollment

60 participants

Start Date

Nov 11, 2023

Study Type

OBSERVATIONAL

Conditions

Intraoperative hypotension

Summary

Perioperative hypotension is a risk factor for perioperative complications. Advances in machine learning and artificial intelligence have produced an algorithm that predicts the occurrence of hypotension episodes by analyzing an arterial pressure waveform. This technology has not been validated in thoracic surgical patients undergoing lung resections with the use of one-lung ventilation (OLV). We planned an observational, prospective multi-centre cohort validation study of the Hypotension Prediction Index (HPI) in patients undergoing lung resection procedures with the use of one-lung ventilation and a lung-protective strategy.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

DEVICEHemoSphere monitor with Acumen Hypotension Prediction Index Software

Two concomitant courses of intraoperative data will be recorded: 1. the arterial waveform and pressure on the standard hemodynamic patient monitor and 2. the data from the HemoSphere monitor with Acumen Hypotension Prediction Index Software

Locations(3)

Faculty of Medicine, NKUA Attikon University Hospital

Athens, Greece

St. John Paul II Hospital in Krakow

Krakow, Małopolska, Poland

Department of Anesthesiology and Intensive Therapy; Department of Pain Research and Treatment, Faculty of Medical Sciences Zabrze

Zabrze, Silesian Voivodeship, Poland

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NCT06202638

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