Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05615168

Enrollment

Registered

2022-11-14

Start date

2022-01-01

Completion date

2022-08-30

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension During Surgery

Brief summary

Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.

Interventions

DIAGNOSTIC_TESTAcumen IQ guided hemodynamic optimization

Hypotension prediction index (HPI) available with the Edwards Acumen IQ sensor will be used as an early warning system and a diagnostic screen will be used to guide therapeutic interventions.

DIAGNOSTIC_TESTFlotrac guided hemodynamic optimization

Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards Flotrac sensor.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients over 18 years of age * patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus) * planned thoracotomy and intraoperative period of one lung ventilation * planned postoperative admission to the ICU

Exclusion criteria

* persistent atrial fibrillation * structural heart defects (shunting or moderate to severe valvular anomalies) * preoperative serum hemoglobin levels \< 120 g/L * severe heart failure classified as New York Heart Association (NYHA) grade IV

Design outcomes

Primary

Measure	Time frame
Time weighted average of area under hypotensive threshold	During surgery

Secondary

Measure	Time frame
Cumulative duration of hypotension	During surgery
Number of hypotensive events	During surgery

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026