Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound (AI_PLUS)

Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound: an Observational Cohort Study.

This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate

Study Overview

• Status: Recruiting
• Conditions: Surgery-Complications; Overload Fluid
• Intervention / Treatment: Other: No intervention

Detailed Description

The primary aim of this study is to develop a machine learning framework to predict major complications after major gastro-intestinal surgery. Secondary aims include combining this framework with point of care ultrasound to determine the best initial resuscitative strategy; and to determine which ultrasound parameters are best predictive of fluid intolerance. Furthermore if the renin angiotensin aldosterone system is more active after liver resection.

Study design:

Single centre observational cohort study

Study population:

Adult patients undergoing elective major gastrointestinal surgery

Primary study parameters/outcome of the study:

The main study endpoint is a machine learning framework based on the hemodynamic profile to predict major complications,especially cardiovascular/pulmonary instability, including, sepsis and septic shock. Data from the ClearSight will be used to collect non-invasive arterial pressure waveforms. point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected

Secondary study parameters/outcome of the study (if applicable):

point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected. Ina subgroup of 40 patients RAAS levels and portal blood samples will be analysed.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: P. Klompmaker, PhD; Phone Number: 020 444 4444; Email: p.klompmaker@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HV
      • Recruiting
      • Amsterdam UMC
      • Contact: A.P. J. Vlaar, PhD; Phone Number: 020 444 4444; Email: a.p.vlaar@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who will undergo elective, major gastrointestinal surgery.

Description

Inclusion Criteria:

• ≥18 years of age.
• elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).

Exclusion Criteria:

• no informed consent
• Patients with major cardiac shunts
• Patients with dialysis shunts or peritoneal dialysis
• Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI> 40, pulmonary fibrosis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	mainly complications such as ICU admission, re-OR, hemodynamic or respiratory instability, death, organ failure	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fluid overload or fluid intolerance	ultrasound measurements such as lung ultrasound and VExUS	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
renin en aldosterone activity	pre and post-opative (day 0 day 1 and day 3) Renin and aldosterone levels in the blood	28 days

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: A.P. J. Vlaar, PhD, Department of Intensive Care, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intensive care unit; Prediction; Gastro-intestinal surgery
• Other Study ID Numbers: NL84107.018.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: As of this moment it is undecided whether or not the individual patient data will be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No