Hypotension Prediction Index (HPI) in Lung Resections

ConditionIntraoperative Hypotension

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorJohn Paul II Hospital, Krakow

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Urgent/emergency procedures.

Patients with known clinically important intracardiac shunts.

Moderate to severe valvular disease.

Preoperative symptomatic arrhythmias including AF.

Trial population

60 consecutive adult patients qualified for open-chest lung resection procedures under general anesthesia and one-lung ventilation will be monitored during the operation using standard invasive hemodynamic monitoring with arterial pressure transducer and concomitantly with HemoSphere monitor with the HPI software attached to the Acumen IQ transducer (Edwards LifeSciences, Irvine, CA, USA).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

HemoSphere monitor with Acumen Hypotension Prediction Index Software
Device
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

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: The arterial pressure and HPI course in 7 time-windows cohorts in one-lung ventilated patients1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

Intraoperative period

Secondary outcomes

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.

Time frame

Intraoperative period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Paul II Hospital, Krakow

Lead sponsor

Source ClinicalTrials.gov

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