Hypotension Prediction Index (HPI) in Lung Resections

January 11, 2024 updated by: Mirosław Ziętkiewicz, John Paul II Hospital, Krakow

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Hypotension Prediction Index (HPI) is a hemodynamic score designed specifically for prediction of the intraoperative hypotension (IOH) episodes. It is based on an algorithm programmed into Edwards Lifesciences HemoSphere monitor clinical platform (Irvine, CA, USA). The HPI is based on a continuous analysis of an arterial pressure waveform. It is processed in addition to the FloTrac algorithm via proprietary Acumen IQ Sensor and uses an artificial intelligence technology. After internal validation, the algorithm was prospectively, externally and clinically validated in general surgical, perioperative patients, cardiovascular surgical patients, and mechanically ventilated COVID-19 ICU patients.

As opposed to conventional monitoring systems, which display physiological parameters in real life, an HPI algorithm detects the earliest changes, multivariate variability and interactions in the physiologic inter-related data on preload, afterload, and contractility to deliver an index predicting an upcoming hypotensive event. Variables used by the patent-protected algorithm to calculate HPI are as follows: heart rate variability (changes in heart rate/changes in MAP); arterial pressure waveform complexity (approximate waveform entropy, sample waveform entropy, frequency domain measure of higher order harmonics); preload parameters (pulse pressure variation PPV, stroke volume variation SVV); contractility parameters (slope of the ascending part of the pressure waveform above time, dP/dt); and afterload parameters (SVR, dynamic arterial elastance Eadyn), but their relative contribution to final index is not revealed.

Final index values of HPI range from 1 to 100, with increasing numbers representing a greater likelihood of an impending hypotensive event. These events are defined as mean arterial pressure (MAP) <65 mmHg occurring for over one minute. HPI values predict the occurrence of hypotension five to fifteen minutes before the event, with sensitivity and specificity in both time-frames of greater than 80%. In most studies, a value of 85 HPI predicts a hypotensive episode, and this value is arbitrarily preprogrammed into the HemoSphere monitor to alert the clinician and allow proactive responses to minimize or even entirely prevent intraoperative hypotension.

Parameters used and incorporated into the HemoSphere monitor can guide a clinician in the optimal management of IOH. These "secondary screen" variables include the left ventricular contractility parameter (dP/dt), dynamic preload parameter (SVV) and afterload parameter dynamic arterial elastance Eadyn.

Maximal left ventricular (LV) pressure rise (LV dP/dt max) is a classical marker of LV performance and systolic function. It is conventionally defined as the change in pressure in the left ventricular cavity over the isovolumetric contraction period and it originally requires LV catheterization. In clinical practice a surrogate peripheral arterial pressure waveform is used to estimate dP/dt value and to predict the need for inotropic support.

SVV is a dynamic preload parameter and represents the difference in the left ventricular stroke volume secondary to changes in intrathoracic pressure induced by mechanical ventilation.

The dynamic arterial elastance Eadyn represents the proportion of pulse-pressure variation (PPV) to SVV. It can be used to assess vascular tone, which can predict arterial pressure response after volume loading and/or potential response to vasopressor administration.

Both PPV and SVV are considered superior to static indices to predict fluid responsiveness. They are both based on heart-lung interactions and reflect hemodynamic cyclic changes induced by mechanical ventilation in the closed-chest condition. Their values are significantly correlated with the magnitude of VT. The current low-tidal volume intraoperative ventilatory strategy protects the lungs, but at the same time lowers the reliability of dynamic indices, particularly in open-chest conditions. Due to limited changes in intrathoracic pressure during the respiratory cycle in open lung conditions, there is a risk of receiving false negative parameter values. PPV and SVV seem to be inaccurate in predicting fluid responsiveness in an open-chest setting during cardiothoracic surgery.

The HPI was validated in general surgery and ICU cases, but not in thoracic surgery one-sided open chest procedures. These procedures include not only significantly abnormal physiologic conditions (open pleura and one-lung protective ventilation) but also a high incidence of sudden manual surgical interventions. All these factors can significantly influence and compromise the HPI performance.

The aim of this study is to validate the HPI technology in open-chest lung resection procedures with the use of one-lung ventilation. The study group will comprise 60 consecutive adult patients qualified for lung resection procedures under general anesthesia with open-chest and one-lung ventilation.

The patients 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). The clinicians will be blinded to the output of the HemoSphere monitor. Hemodynamic waveforms and HPI prediction data including hypotensive events (IOH) will be recorded from the time of arterial cannula insertion until leaving the operation room. Recorded data will be divided into seven cohorts, represented by separate time frames:

0. Pre-induction baseline, supine, spontaneous breathing (if available and arterial cannula inserted pre-induction)

  1. Supine, closed-chest anaesthetized, intubated, two-lung ventilation
  2. Lateral decubitus, closed chest, two-lung ventilation
  3. Lateral decubitus, closed chest, one-lung ventilation (OLV)
  4. Lateral decubitus, open chest, one-lung ventilation (OLV)
  5. Lateral decubitus, closed chest, two-lung ventilation post-resection
  6. Supine, closed-chest, two-lung ventilation

We will estimate the sensitivity (recall) and positive predictive value (precision) of the HPI algorithm and describe the number of false alarms as well as missed events without explicitly referring to specificity or negative predictive value.

Study conduct and reporting will be performed under the STARD guidelines.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 12462
  • Poland
    • Małopolska
      • Kraków, Małopolska, Poland, 31-202
        • Recruiting
        • St. John Paul II Hospital in Krakow
        • Contact:
    • Śląskie
      • Zabrze, Śląskie, Poland, 40-055
        • Recruiting
        • Department of Anesthesiology and Intensive Therapy; Department of Pain Research and Treatment, Faculty of Medical Sciences Zabrze
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The arterial pressure and HPI course in 7 time-windows cohorts in one-lung ventilated patients
60 consecutive adult patients qualified for open-chest lung resection procedures under general anesthesia with 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). The clinicians will be blinded to the output of the HemoSphere monitor. Hemodynamic waveforms and HPI prediction data will be recorded from the time of arterial cannula insertion until leaving the operation room. HPI values and intraoperative hemodynamic course including intraoperative hypotensive events (IOH) will be recorded at all stages of the procedure.
Device: HemoSphere 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value
Time Frame: Intraoperative period
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event rate
Time Frame: Intraoperative period
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Paul II Hospital, Krakow

Investigators

  • Principal Investigator: Mirosław Ziętkiewicz, MD, PhD, 2nd Anesthesiology and Intensive Care Unit, John Paul II Hospital, Prądnicka St. 80, Kraków, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NB.060.1.011.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraoperative Hypotension

Clinical Trials on HemoSphere monitor with Acumen Hypotension Prediction Index Software

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe