NCT04807036

Brief Summary

The investigators would like to explore whether Hypotension Prediction Index during and immediately after surgery can be used to improve the accuracy of scores that predict postoperative problems.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 12, 2021

Last Update Submit

March 18, 2021

Conditions

Surgery--Complications

Keywords

Perioperative medicineRiskPredictive analyticsHypotension Prediction IndexObservational cohort

Outcome Measures

Primary Outcomes (1)

  • Days alive and out of hospital

    Number of days that the participant is alive and out of hospital

    Day 30

Secondary Outcomes (11)

  • Morbidity

    Day 5

  • Complications

    From the date and time of surgery until hospital discharge

  • Number of nights that a participant spends at home

    Day 30 and 90

  • Mortality

    Day 30 and 1 year

  • Quality of Recovery - 15 score (QoR-15)

    Day 90

  • +6 more secondary outcomes

Interventions

Hypotension Prediction IndexDEVICE

HemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are: 1. referred for routine cardiopulmonary exercise testing 2. scheduled for elective surgery and expected to have \>24 hours postoperative hospital stay

You may qualify if:

  • Patients who:
  • are referred for CPET
  • are scheduled for elective surgery and expected to have \>24 hours postoperative hospital stay
  • will receive invasive arterial pressure monitoring as part of routine care
  • are aged 18 or over
  • have the capacity to give consent to participate

You may not qualify if:

  • Patients who:
  • do not proceed to surgery following CPET referral
  • are aged less than 18 years
  • do not have capacity to consent
  • decline to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Professor D Levett

    University Hospital Southampton NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Badger

CONTACT

023 8120j.e.g.badger@soton.ac.uk

Professor M Grocott

CONTACT

mike.grocott@soton.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 19, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2026

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share