Artificial Intelligence - to Predict and Prevent Hypotension During Surgery

NCT06240234 | Not Yet Recruiting

• 1 other identifier: CIP_AI_hypotension_study_V01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this medtech clinical trial is to develop and evaluate a machine learning algoritm to predict low blood pressure episodes during major surgery. The main questions it aims to answer are:

• Could a novel method for cardiac output estimation through alterations in carbon dioxide improve the performance of a blood pressure based algoritm in order to predict low blood pressure episodes during major abdominal surgery?
• Will the predictive performance of the algoritm improve with the addition of other patient specific data?
• Do the estimated cardiac output and central venous saturation by the novel method agree with our invasive arterial pressure method for cardiac output, and samples via a central venous line, respectively? 300 participants will be anesthetized with total intravenous anesthesia and ventilated with the novel carbon dioxide based method, and arterial and central venous blood gases will be taken regularly throughout the operation. All physiological data will be stored for later analyses and development of the algoritm by machine learning methods. No other invasive interventions will be performed outside our standard clinical peroperative protocol.

Conditions

Monitoring, Intraoperative

Keywords

Hypotension; Artificial intelligence; Capnodynamics

Outcome Measures

Primary Outcomes (1)

• Accuracy of prediction of hypotension 5 minutes ahead of time using capnodynamics and continuous arterial blood pressure measurement.

  Specified as the area under receiver operating characteristic curve (AUROC).

  6-12 hours

Secondary Outcomes (2)

• Agreement (precision, bias) for the capnodynamic method vs our standard perioperative method for cardiac output

  6-12 hours

• Agreement (precision, bias) for the capnodynamic method vs our standard perioperative method for central venous satuation.

  6-12 hours

Study Arms (1)

Capnodynamic method arm

OTHER

Only one arm will be used since all patients will be ventilated using the novel capnodynamic method. The algoritm will then be developed by including or omitting the capnodynamic data in addition to the curve data from the arterial line.

Device: Capnodynamic method

Interventions

Capnodynamic method DEVICE

All patients will be ventilated using the novel capnodynamic method, incorporated in a modified Maquet servo I ventilator. For this reason, all patients will be anesthetized using total intravenous anesthesia.

Capnodynamic method arm

Eligibility Criteria

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

You may qualify if:

• patients scheduled for elective major abdominal surgery at Karolinska University Hospital.

You may not qualify if:

• Cardiac arrytmias, such as atrial fibrillation Severe pulmonary diseases, including severe chronic obstructive pulmonary disease Patient unable to understand or speak swedish and thereby dificulties to give informed concent.

Sponsors & Collaborators

• Region Stockholm: lead
• KTH Royal Institute of Technology: collaborator
• Getinge Group: collaborator

Related Publications (9)

• Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.

  PMID: 29369117 BACKGROUND

• Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.

  PMID: 20966436 BACKGROUND

• Sun Y, Chai F, Pan C, Romeiser JL, Gan TJ. Effect of perioperative goal-directed hemodynamic therapy on postoperative recovery following major abdominal surgery-a systematic review and meta-analysis of randomized controlled trials. Crit Care. 2017 Jun 12;21(1):141. doi: 10.1186/s13054-017-1728-8.

  PMID: 28602158 BACKGROUND

• Yuan J, Sun Y, Pan C, Li T. Goal-directed fluid therapy for reducing risk of surgical site infections following abdominal surgery - A systematic review and meta-analysis of randomized controlled trials. Int J Surg. 2017 Mar;39:74-87. doi: 10.1016/j.ijsu.2017.01.081. Epub 2017 Jan 23.

  PMID: 28126672 BACKGROUND

• Wijnberge M, Schenk J, Bulle E, Vlaar AP, Maheshwari K, Hollmann MW, Binnekade JM, Geerts BF, Veelo DP. Association of intraoperative hypotension with postoperative morbidity and mortality: systematic review and meta-analysis. BJS Open. 2021 Jan 8;5(1):zraa018. doi: 10.1093/bjsopen/zraa018.

  PMID: 33609377 BACKGROUND

• Hallsjo Sander C, Hallback M, Wallin M, Emtell P, Oldner A, Bjorne H. Novel continuous capnodynamic method for cardiac output assessment during mechanical ventilation. Br J Anaesth. 2014 May;112(5):824-31. doi: 10.1093/bja/aet486. Epub 2014 Feb 18.

  PMID: 24554544 BACKGROUND

• Sigmundsson TS, Ohman T, Hallback M, Redondo E, Sipmann FS, Wallin M, Oldner A, Hallsjo Sander C, Bjorne H. Performance of a capnodynamic method estimating effective pulmonary blood flow during transient and sustained hypercapnia. J Clin Monit Comput. 2018 Apr;32(2):311-319. doi: 10.1007/s10877-017-0021-3. Epub 2017 May 11.

  PMID: 28497180 BACKGROUND

• Sigmundsson TS, Ohman T, Hallback M, Suarez-Sipmann F, Wallin M, Oldner A, Hallsjo-Sander C, Bjorne H. Comparison between capnodynamic and thermodilution method for cardiac output monitoring during major abdominal surgery: An observational study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1242-1252. doi: 10.1097/EJA.0000000000001566.

  PMID: 34155171 BACKGROUND

• Hallsjo Sander C, Hallback M, Suarez Sipmann F, Wallin M, Oldner A, Bjorne H. A novel continuous capnodynamic method for cardiac output assessment in a porcine model of lung lavage. Acta Anaesthesiol Scand. 2015 Sep;59(8):1022-31. doi: 10.1111/aas.12559. Epub 2015 Jun 4.

  PMID: 26041115 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Greg Winski, Dr

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Winski, Dr

CONTACT

+46812380000; greg.winski@regionstockholm.se

Haakan Bjoerne, PhD

CONTACT

+46812374719; hakan.bjorne@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: February 2, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share