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Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index

Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04807036
Acronym
CIPHER-HPI
Enrollment
150
Registered
2021-03-19
Start date
2021-04-30
Completion date
2026-04-30
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery--Complications

Keywords

Perioperative medicine, Risk, Predictive analytics, Hypotension Prediction Index, Observational cohort

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.

Interventions

HemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
University of Southampton
CollaboratorOTHER
University Hospital Southampton NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Days alive and out of hospitalDay 30Number of days that the participant is alive and out of hospital

Secondary

MeasureTime frameDescription
ComplicationsFrom the date and time of surgery until hospital dischargeWhether or not a participant develops complications as measured using Clavien Dindo
Number of nights that a participant spends at homeDay 30 and 90
MortalityDay 30 and 1 yearNumber of participants who die within 30 days or 1 year of surgery
Quality of Recovery - 15 score (QoR-15)Day 90A 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
Return to pre-surgery functioningDay 90Participants 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.
MorbidityDay 5Whether or not a participant has morbidity as measured using the post operative morbidity survey
Hospital length of stayBetween the date of surgery and hospital discharge (primary admission)Number of nights spent in hospital
Hospital readmission30 daysReadmission to hospital following discharge
Total length of hospital stay30 daysNumber of nights spent in hospital
ReoperationDay 30Number of unplanned operations
Total length of critical care stayFirst 30 days after surgeryNumber of nights spent in Critical Care

Contacts

Primary ContactJames Badger
j.e.g.badger@soton.ac.uk023 8120
Backup ContactProfessor M Grocott
mike.grocott@soton.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026