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The Predict H Trial

NCT04301102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-12-09

No results posted yet for this study

Summary

The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.

Conditions

  • Intraoperative Hypotension

Interventions

DEVICE

Hemosphere platform® together with the FloTrac Acumen IQ® sensor

Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management. It incorporates predictive parameters such as the hypotension prediction index and decision support parameters such as dynamic arterial elastance and maximum dP / dT. It also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...).

DEVICE

Hemosphere platform® together with the FloTrac® sensor

Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management. It also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...).

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Juan Victor Lorente

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-02-28
Completion
2022-06-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301102 on ClinicalTrials.gov