Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index (CIPHER-HPI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery--Complications
• Intervention / Treatment: Device: Hypotension Prediction Index

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: James Badger; Phone Number: 5308 023 8120; Email: j.e.g.badger@soton.ac.uk
• Study Contact Backup: Name: Professor M Grocott; Email: mike.grocott@soton.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

Patients who:

1. are referred for CPET
2. are scheduled for elective surgery and expected to have >24 hours postoperative hospital stay
3. will receive invasive arterial pressure monitoring as part of routine care
4. are aged 18 or over
5. have the capacity to give consent to participate

Exclusion Criteria:

Patients who:

1. do not proceed to surgery following CPET referral
2. are aged less than 18 years
3. do not have capacity to consent
4. decline to consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	From the date and time of surgery until hospital discharge
Number of nights that a participant spends at home		Day 30 and 90
Mortality	Number of participants who die within 30 days or 1 year of surgery	Day 30 and 1 year
Quality of Recovery - 15 score (QoR-15)	A 15 question survey, where a number of different items are scored on a 10 point numeric scale. Higher scores represent better outcomes as reported by the participant	Day 90
Return to pre-surgery functioning	Participants ability to return to work or usual home activities as measured by item 8 of the Quality of Recovery - 15 score. This will be scored on a 10 point numeric scale. Higher scores represent better outcomes as reported by the patient.	Day 90
Total length of critical care stay	Number of nights spent in Critical Care	First 30 days after surgery
Hospital length of stay	Number of nights spent in hospital	Between the date of surgery and hospital discharge (primary admission)
Hospital readmission	Readmission to hospital following discharge	30 days
Total length of hospital stay	Number of nights spent in hospital	30 days
Reoperation	Number of unplanned operations	Day 30

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: University of Southampton; Edwards Lifesciences
• Investigators: Principal Investigator: Professor D Levett, University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): April 1, 2026

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (ACTUAL): March 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Risk; Perioperative medicine; Predictive analytics; Hypotension Prediction Index; Observational cohort
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: RHM CRI0405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes