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Hypotension Decision Assist - Use, Safety and Efficacy

NCT05101590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-22

No results posted yet for this study

Summary

This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. If successful, this study will provide evidence that the use of HDA facilitates beneficial outcomes for patients who have this device used.

Conditions

  • Intraoperative Hypotension

Interventions

DEVICE

Monitored by HDA

Participants undergoing elective major surgery with an arterial line as part of their standard care and additional monitoring with HDA as part of their care.

Sponsors & Collaborators

  • University Hospital Birmingham NHS Foundation Trust

    collaborator OTHER

  • Innovate UK

    collaborator OTHER_GOV

  • Directed Systems Limited

    lead INDUSTRY

Principal Investigators

  • Thomas Clutton-Brock · University Hospital Birmingham NHS Foundation Trust

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United Kingdom

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 NCT05101590 on ClinicalTrials.gov