Intraoperative Hypotension Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Faculty of Medicine, NKUA Attikon University Hospital | Athens | |
Poland | St. John Paul II Hospital in Krakow | Kraków | Malopolska |
Poland | Department of Anesthesiology and Intensive Therapy; Department of Pain Research and Treatment, Faculty of Medical Sciences Zabrze | Zabrze | Slaskie |
Lead Sponsor | Collaborator |
---|---|
John Paul II Hospital, Krakow |
Greece, Poland,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive predictive value | Positive predictive value (precision) of the Hypotension Prediction Index (HPI) algorithm (95% CI) for prediction of IOH episodes at different time intervals (5, 10, 15 minutes) in lung resection surgery patients
Sensitivity (recall) of the Hypotension Prediction Index (HPI) algorithm (95% CI) for prediction of IOH episodes at different time intervals (5, 10, 15 minutes) in lung resection surgery patients. Calibration curve (incidence of IOH vs. HPI; 95% CI) |
Intraoperative period | |
Secondary | Event rate | Event rate across the observed spectrum of HPI values - i.e. the number of false alarms as well as missed events without explicitly referring to specificity or negative predictive value.
Average values of dynamic preload parameters PPV, SVV and arterial elastance and their change during OLV. |
Intraoperative period |
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