Continuously Iterative Perioperative Holistic Evaluation... | NCT04807036

Studies
Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index

NCT04807036

Sponsor

University Hospital Southampton NHS Foundation Trust

Status

Unknown status

Last Update Posted

Mar 19, 2021Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Surgery--Complications

Interventions

Hypotension Prediction Index

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2021Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 12, 2021

First Submission Date that Met QC Criteria

Mar 18, 2021

First Posted Date

Mar 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2021

Last Update Posted Date

Mar 19, 2021Actual

Name	Class
Edwards Lifesciences	INDUSTRY
University of Southampton	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

It is known that some patients have a prolonged and difficult recovery after major surgery, which impacts their long-term health and wellbeing. A major issue is that scores for predicting recovery are typically generated only once in the period before surgery, but subsequent events during and immediately after surgery can also alter the likelihood of a prolonged and difficult recovery.

One such event appears to be low blood pressure (hypotension). Hypotension Prediction Index can be calculated from routine blood pressure measurements, and is an indicator of blood pressure instability. The investigators propose that Hypotension Prediction Index during and immediately after surgery may be used to improve their accuracy of scores that predict postoperative problems.

To explore this, the investigators will collect information about the health and care needs, surgery and postoperative recovery of adult patients' requiring major surgery. This data will be taken from hospital information systems, a bedside monitor, test reports, a questionnaire and National Databases. The investigators will then use statistical models to determine whether Hypotension Prediction Index improves the accuracy of preoperative scores for predicting postoperative problems.

Ultimately, the investigators hope to create a tool for predicting how well a patient will recover based on the information available at any given point in time. Healthcare professionals will be able to use this tool to identify and support the needs of patients who need extra help recovering from major surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypotension Prediction Index	Device	HemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Days alive and out of hospital	Number of days that the participant is alive and out of hospital	Day 30

Secondary Outcomes

Measure	Description	Time Frame
Morbidity	Whether or not a participant has morbidity as measured using the post operative morbidity survey	Day 5
Complications	Whether or not a participant develops complications as measured using Clavien Dindo

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are:

referred for routine cardiopulmonary exercise testing
scheduled for elective surgery and expected to have >24 hours postoperative hospital stay

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
James Badger	Contact	023 8120	5308	j.e.g.badger@soton.ac.uk
Professor M Grocott	Contact			mike.grocott@soton.ac.uk

Overall Officials

Name	Affiliation	Role
Professor D Levett	University Hospital Southampton NHS Foundation Trust	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided