Surgery--ComplicationsCIPHER-HPINCT04807036
Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index
An observational study of Surgery--Complications, run by University Hospital Southampton NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Hypotension Prediction Index
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Professor M Grocott contact
About this study
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.
Read the 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.
- Conditions
- Surgery--Complications
- Being tested
- Hypotension Prediction Index
- Keywords
- Perioperative medicine, Risk, Predictive analytics, Hypotension Prediction Index, Observational cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension Prediction IndexDevice
HemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital
Number of days that the participant is alive and out of hospital
Measured: Day 30
Secondary outcomes (11)
Morbidity
Whether or not a participant has morbidity as measured using the post operative morbidity survey
Measured: Day 5
Complications
Whether or not a participant develops complications as measured using Clavien Dindo
Measured: From the date and time of surgery until hospital discharge
Number of nights that a participant spends at home
Measured: Day 30 and 90
Mortality
Number of participants who die within 30 days or 1 year of surgery
Measured: 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
Measured: 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.
Measured: Day 90
Total length of critical care stay
Number of nights spent in Critical Care
Measured: First 30 days after surgery
Hospital length of stay
Number of nights spent in hospital
Measured: Between the date of surgery and hospital discharge (primary admission)
Hospital readmission
Readmission to hospital following discharge
Measured: 30 days
Total length of hospital stay
Number of nights spent in hospital
Measured: 30 days
Reoperation
Number of unplanned operations
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Professor D Levett, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807036
- Sponsor's protocol ID
- RHM CRI0405
- Acronym
- CIPHER-HPI
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuously Iterative Perioperative Holistic Evaluation of Risk and Hypotension Prediction Index
- ClinicalTrials.gov ID
- NCT04807036
- Acronym / sponsor ID
- CIPHER-HPI / RHM CRI0405
- Conditions
- Surgery--Complications
- Keywords
- Perioperative medicine, Risk, Predictive analytics, Hypotension Prediction Index, Observational cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Edwards Lifesciences, University of Southampton
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- do not proceed to surgery following CPET referral
- are aged less than 18 years
- do not have capacity to consent
- decline to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotension Prediction IndexHemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature | Device | – |
Primary outcome
Days alive and out of hospital
Time frame: Day 30
Number of days that the participant is alive and out of hospital
11 secondary outcomes
Morbidity
Time frame: Day 5
Complications
Time frame: From the date and time of surgery until hospital discharge
Number of nights that a participant spends at home
Time frame: Day 30 and 90
Mortality
Time frame: Day 30 and 1 year
Quality of Recovery - 15 score (QoR-15)
Time frame: Day 90
Return to pre-surgery functioning
Time frame: Day 90
Total length of critical care stay
Time frame: First 30 days after surgery
Hospital length of stay
Time frame: Between the date of surgery and hospital discharge (primary admission)
Hospital readmission
Time frame: 30 days
Total length of hospital stay
Time frame: 30 days
Reoperation
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor M Grocott contact
Professor D Levett principal investigator
University Hospital Southampton NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by University Hospital Southampton NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Badger (023 8120 ext. 5308, j.e.g.badger@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and out of hospital (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.