Post Anaesthesia Care Hypotension Prevention

NCT05844774 | Unknown

• 1 other identifier: NL81361.091
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. The main question this trial aims to answer is: • Does the use of the hypertension prediction index (HPI) decrease hypotension during surgery and in the post-operative period? During and after their surgery, participants in the intervention group will be treated according to the HPI-algorithm. Participants in the control group will be treated following the standard of care.

Conditions

Hypotension During Surgery

Keywords

Laparotomy; Hypotension; Goal Directed Therapy; Post-operative; Prediction; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Time Weighted Average of hypotension

  Time Weighted Average (TWA) is measured as (depth of hypotension in mmHg below a MAP op 65mmHg x time in minutes spent below a MAP of 65mmHg) ÷ total duration of surgery/PACU admission in minutes)

  During the accumulative duration of surgery and PACU admission

Secondary Outcomes (9)

• Frequency and duration of hypotension

  During surgery and in the 24 hours following surgery

• Frequency and duration of hypertension

  During surgery and in the 24 hours following surgery

• Total amount of administered fluids

  During surgery and in the 24 hours following surgery

• Total administration of vasopressors

  During surgery and in the 24 hours following surgery

• Total administration of inotropy

  During surgery and in the 24 hours following surgery

Study Arms (2)

HPI-intervention algorithm

EXPERIMENTAL

In the intervention group the HemoSphere screen is visible and the anesthesiologist and PACU personal are instructed to follow the algorithm (chapter 4) in case of a HPI \>85%. The purpose of the alarm at 85% and the presented algorithm is to prevent hypotension. If hypotension occurs, it should be treated as according to the standard of care.

Device: HPI (using HemoSphere) - guided algorithm

Control group

OTHER

Patients in the control group are connected to the HemoSphere monitor to evaluate the TWA of hypotension in this group. The screen is not visible to the anesthesiologist or PACU personal and the alarm is set silent. It will be explained to the anesthesiologist and PACU personal that the patients are included to this study and that a blood pressure with a MAP of 65 mmHg should be monitored.

Device: Treatment of hypotension following standard of care

Interventions

HPI (using HemoSphere) - guided algorithm DEVICE

Treatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%.

HPI-intervention algorithm

Treatment of hypotension following standard of care DEVICE

Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old
• Patients planned to undergo laparotomy surgery
• Patients that will receive an invasive arterial catheter as part of their procedure
• Patients that are planned to go to the post anaesthetic care unit (PACU) post-operatively

You may not qualify if:

• Patients with known arrythmias
• Patients with known severe heart valve disease
• Patients with the need for dialysis
• Clamping of the aorta or Pringle's manoeuvre during surgery
• Emergency procedures

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Edwards Lifesciences: collaborator

MeSH Terms

Conditions

Hypotension

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Van Eijk

  Coordinating Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Van Eijk

CONTACT

0624501517; lucas.vaneijk@radboudumc.nl

Sieffers

CONTACT

0646306609; matthijs.sieffers@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 control group, 1 intervention group without cross-over

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 6, 2023
• Study Start: May 22, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share