NCT03376347

Brief Summary

Reducing intraoperative hypotension using FlotracIQ with HPI software.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

December 3, 2017

Last Update Submit

January 9, 2020

Conditions

Intraoperative Hypotension

Keywords

intraoperativehypotensionHypotension Probability IndexHPI

Outcome Measures

Primary Outcomes (1)

  • TWA hypotension (measured with FlotracIQ)

    Time weighted average spent in hypotension, defined as MAP \<65mmHg for ≥1min

    intraoperative, starting 15 minutes after induction

Secondary Outcomes (9)

  • Incidence of hypotension (measured with FlotracIQ)

    intraoperative, starting 15 minutes after induction

  • Time spent in hypotension (measured with FlotracIQ)

    intraoperative, starting 15 minutes after induction

  • TWA hypertension (measured with FlotracIQ)

    intraoperative, starting 15 minutes after induction

  • Percentage of time in hypertension (measured with FlotracIQ)

    intraoperative, starting 15 minutes after induction

  • Incidence of hypertension (measured with FlotracIQ)

    intraoperative, starting 15 minutes after induction

  • +4 more secondary outcomes

Study Arms (2)

Conventional arm

NO INTERVENTION

Institutional Standard of Care with intention to keep MAP\> 65 mmHg. The FlotracIQ will be connected, but fully covered.

Treatment arm

ACTIVE COMPARATOR

FlotracIQ with HPI algorithm.

Device: FlotracIQ with HPI algorithm

Interventions

FlotracIQ with HPI algorithmDEVICE

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.

Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center Amsterdam

Amsterdam, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 32065827DERIVED

  • 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.

    PMID: 31601239DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • M.W. Hollmann, MD, PhD

    Academic Medical Center (AMC), Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor, PhD

Study Record Dates

First Submitted

December 3, 2017

First Posted

December 18, 2017

Study Start

November 8, 2017

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)