Intraoperative Implementation of the Hypotension Probability Indicator

Intraoperative Hypotension Clinical Trial

— HYPE  

Official title:

HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376347
• Other study ID #: NL 6211501817
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: March 20, 2019

Study information

• Verified date: January 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reducing intraoperative hypotension using FlotracIQ with HPI software.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TWA hypotension (measured with FlotracIQ)	Time weighted average spent in hypotension, defined as MAP <65mmHg for =1min	intraoperative, starting 15 minutes after induction
Secondary	Incidence of hypotension (measured with FlotracIQ)	Incidence of hypotension, defined as MAP <65mmHg for =1min	intraoperative, starting 15 minutes after induction
Secondary	Time spent in hypotension (measured with FlotracIQ)	Time spent in hypotension, in minutes, defined as MAP <65mmHg for =1min	intraoperative, starting 15 minutes after induction
Secondary	TWA hypertension (measured with FlotracIQ)	Time weighted average spent in hypertension, defined as MAP >100 mmHg for =1min	intraoperative, starting 15 minutes after induction
Secondary	Percentage of time in hypertension (measured with FlotracIQ)	Percentage of time in hypertension, defined as MAP >100 mmHg for =1min	intraoperative, starting 15 minutes after induction
Secondary	Incidence of hypertension (measured with FlotracIQ)	Incidence of hypertension, defined as MAP >100 mmHg for =1min.	intraoperative, starting 15 minutes after induction
Secondary	Treatment choice (CRF, EPD)	Medication used to prevent/treat hypotension. A study member is present at the OR to make notes	intraoperative, starting 15 minutes after induction
Secondary	Treatment dose (CRF, EPD)	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
Secondary	Time to treatment (CRF)	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
Secondary	Diagnostic guidance protocol deviations (CRF)	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