- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376347
Intraoperative Implementation of the Hypotension Probability Indicator (HYPE)
January 9, 2020 updated by: D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial
Reducing intraoperative hypotension using FlotracIQ with HPI software.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Intraoperative hypotension occurs often.
Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia.
Currently treatment of these hypotensive episodes is not proactive.
Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases.
Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amsterdam, Netherlands
- Academic Medical Center Amsterdam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years or older
- Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
- Planned to receive general anaesthesia
- Planned to receive an arterial line during surgery
- Aim for MAP of 65 mmHg during surgery
- Being able to give written informed consent prior to surgery
Exclusion Criteria:
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
- Severe cardiac arrhythmias including atrial fibrillation
- Requiring dialysis
- Liver surgery
- Vascular surgery with clamping of the aorta
- Perioperative Goal Directed Therapy (PGDT) protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Conventional arm
Institutional Standard of Care with intention to keep MAP> 65 mmHg.
The FlotracIQ will be connected, but fully covered.
|
|
ACTIVE_COMPARATOR: Treatment arm
FlotracIQ with HPI algorithm.
|
FlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line.
The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what.
Timing of treatment and choice of treatment is then left to the discretion of the attending physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TWA hypotension (measured with FlotracIQ)
Time Frame: intraoperative, starting 15 minutes after induction
|
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min
|
intraoperative, starting 15 minutes after induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of hypotension (measured with FlotracIQ)
Time Frame: intraoperative, starting 15 minutes after induction
|
Incidence of hypotension, defined as MAP <65mmHg for ≥1min
|
intraoperative, starting 15 minutes after induction
|
Time spent in hypotension (measured with FlotracIQ)
Time Frame: intraoperative, starting 15 minutes after induction
|
Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min
|
intraoperative, starting 15 minutes after induction
|
TWA hypertension (measured with FlotracIQ)
Time Frame: intraoperative, starting 15 minutes after induction
|
Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min
|
intraoperative, starting 15 minutes after induction
|
Percentage of time in hypertension (measured with FlotracIQ)
Time Frame: intraoperative, starting 15 minutes after induction
|
Percentage of time in hypertension, defined as MAP >100 mmHg for ≥1min
|
intraoperative, starting 15 minutes after induction
|
Incidence of hypertension (measured with FlotracIQ)
Time Frame: intraoperative, starting 15 minutes after induction
|
Incidence of hypertension, defined as MAP >100 mmHg for ≥1min.
|
intraoperative, starting 15 minutes after induction
|
Treatment choice (CRF, EPD)
Time Frame: intraoperative, starting 15 minutes after induction
|
Medication used to prevent/treat hypotension.
A study member is present at the OR to make notes
|
intraoperative, starting 15 minutes after induction
|
Treatment dose (CRF, EPD)
Time Frame: intraoperative, starting 15 minutes after induction
|
Dose of medication used to prevent/treat hypotension.
A study member is present at the OR to make notes
|
intraoperative, starting 15 minutes after induction
|
Time to treatment (CRF)
Time Frame: intraoperative, starting 15 minutes after induction
|
time to treatment of hypotension, defined as MAP <65mmHg for ≥1min.
A study member is present at the OR to make notes
|
intraoperative, starting 15 minutes after induction
|
Diagnostic guidance protocol deviations (CRF)
Time Frame: intraoperative, starting 15 minutes after induction
|
Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
|
intraoperative, starting 15 minutes after induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: M.W. Hollmann, MD, PhD, Academic Medical Center (AMC), Amsterdam
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
- Wijnberge M, Schenk J, Terwindt LE, Mulder MP, Hollmann MW, Vlaar AP, Veelo DP, Geerts BF. The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. Trials. 2019 Oct 11;20(1):582. doi: 10.1186/s13063-019-3637-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 8, 2017
Primary Completion (ACTUAL)
March 20, 2019
Study Completion (ACTUAL)
March 20, 2019
Study Registration Dates
First Submitted
December 3, 2017
First Submitted That Met QC Criteria
December 15, 2017
First Posted (ACTUAL)
December 18, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2020
Last Update Submitted That Met QC Criteria
January 9, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 6211501817
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
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intraoperative Hypotension
-
Tampere University Hospitalgeneral electric healthcare FinlandCompletedIntraoperative Complications | Intraoperative Hypotension | Intraoperative HypertensionFinland
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Edwards LifesciencesCompletedHypotension | Intraoperative Hypotension | Postoperative HypotensionNetherlands
-
John Paul II Hospital, KrakowRecruiting
-
Seoul National University HospitalRecruitingIntraoperative HypotensionKorea, Republic of
-
Universitätsklinikum Hamburg-EppendorfRecruitingIntraoperative HypotensionGermany
-
zhiqiang zhouRecruitingIntraoperative HypotensionChina
-
Seoul National University HospitalRecruitingIntraoperative HypotensionKorea, Republic of
-
Attikon HospitalRecruitingIntraoperative HypotensionGreece
-
University of Texas Southwestern Medical CenterTexas Health ResourcesRecruiting
-
Chang Gung Memorial HospitalRecruitingIntraoperative HypotensionTaiwan
Clinical Trials on FlotracIQ with HPI algorithm
-
Attikon HospitalCompletedHypotension During SurgeryGreece
-
University of GiessenEdwards LifesciencesCompletedMyocardial Injury | Renal Failure | Hypotension | Anesthesia | Hemodynamic InstabilityGermany
-
Attikon HospitalRecruitingHypotension During Surgery | Prevention of HypotensionGreece
-
Radboud University Medical CenterEdwards LifesciencesNot yet recruitingHypotension During Surgery
-
Moorfields Eye Hospital NHS Foundation TrustCompletedGlaucoma | HealthyUnited Kingdom
-
University of CataniaMarinella Astuto; Carmelo Minardi; Mirko Mineri; Francesco Vasile; Gaetano Joseph... and other collaboratorsCompletedBrain Injuries | Renal Failure | Hypotension | Endothelial DysfunctionItaly
-
Ewha Womans University Mokdong HospitalRecruitingUrologic Diseases | Prostate Cancer | Renal CancerKorea, Republic of
-
Ewha Womans University Mokdong HospitalCompleted
-
Keimyung University Dongsan Medical CenterBiotronik SE & Co. KGCompletedHeart Failure | Sick Sinus Syndrome | PacemakerKorea, Republic of
-
Fisher and Paykel HealthcareNot yet recruiting