Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index

Surgery--Complications Clinical Trial

— CIPHER-HPI  

Official title:

Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04807036
• Other study ID #: RHM CRI0405
• Status: Not yet recruiting
• Start date: April 2021
• Est. completion date: April 2026

Study information

• Verified date: March 2021
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: James Badger
• Phone: 023 8120
• Email: j.e.g.badger[@]soton.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2026
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Surgery--Complications

Intervention

Device:
• Hypotension Prediction Index
HemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	Edwards Lifesciences, University of Southampton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive and out of hospital	Number of days that the participant is alive and out of hospital	Day 30
Secondary	Morbidity	Whether or not a participant has morbidity as measured using the post operative morbidity survey	Day 5
Secondary	Complications	Whether or not a participant develops complications as measured using Clavien Dindo	From the date and time of surgery until hospital discharge
Secondary	Number of nights that a participant spends at home		Day 30 and 90
Secondary	Mortality	Number of participants who die within 30 days or 1 year of surgery	Day 30 and 1 year
Secondary	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
Secondary	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
Secondary	Total length of critical care stay	Number of nights spent in Critical Care	First 30 days after surgery
Secondary	Hospital length of stay	Number of nights spent in hospital	Between the date of surgery and hospital discharge (primary admission)
Secondary	Hospital readmission	Readmission to hospital following discharge	30 days
Secondary	Total length of hospital stay	Number of nights spent in hospital	30 days
Secondary	Reoperation	Number of unplanned operations	Day 30