Hypotension Predictive Index Effect on Intraoperative Hypotension During Pancreatic Surgery.

NCT06097052 | Completed FDA Device

• 1 other identifier: EHPI-Pan-15/23
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative hypotension (IOH) is a sudden clinical phenomenon that occurs frequently during general anesthesia. Prevention of IOH has been linked to reduced postoperative organ damage and decreased incidence of perioperative complications. Oncological patients with reduced preoperative physiological reserves may be especially vulnerable to IOH deleterious effects, especially when exposed to prolonged surgical time increase, as it is the case for patients undergoing pancreatic surgery. The investigators aim to study introduction of a new technology able to predict hypotensive events (Hypotension Predictive Index, HPI Acumen™) in terms of its effects on IOH occurrence and burden in patients undergoing pancreatic surgery. The investigators will enroll patients before and after the introduction of HPI monitoring. Further, differences in postoperative outcomes and perioperative complications between before and after populations will be investigated.

Conditions

Hypotension During Surgery; Perioperative Complication

Keywords

hypotension; perioperative; complications; hemodynamic

Outcome Measures

Primary Outcomes (1)

• Time-weighted average of Mean Arterial Pressure < 65mmHg

  Area under the threshold of MAP 65mmHg normalized for the total duration of surgery in minutes

  intraoperative

Secondary Outcomes (11)

• Average intraoperative Mean Arterial Pressure

  intraoperative

• Frequency of hypotensive events

  intraoperative

• Average absolute time spent during Mean Arterial Pressure < 65mmHg

  intraoperative

• Time-weighted average of Mean Arterial Pressure < 55mmHg

  intraoperative

• Time-weighted average of Mean Arterial Pressure > 100mmHg

  intraoperative

Study Arms (2)

FloTrac

Subject received standard advanced hemodynamic monitoring. Hypotensive episodes were treated using a reactive approach.

HPI

Subject were monitored using the hypotension predictive index coupled with standard advanced hemodynamic monitoring. Hypotensive episodes were treated using a proactive approach.

Device: Hypotension Predictive Index

Interventions

Hypotension Predictive Index DEVICE

Introduction of Hypotension Predictive index and transition from a reactive to a proactive approach of intraoperative hypotension treatment.

HPI

Eligibility Criteria

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

Study Population

Subjects undergoing general anesthesia for elective pancreatic surgery consecutively recruited before and after the introduction of Hypotension Predictive Index technology.

You may qualify if:

• Subjects aged 18 years or older.
• Subjects scheduled for major open pancreatic surgery.
• Subjects monitored with FloTrac or HPI invasive arterial blood pressure monitoring.
• Total surgical time \> 360min.

You may not qualify if:

• Subjects aged 90 years or older
• Subjects classified as ASA IV/V/VI
• Subjects undergoing urgent or emergency surgery

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Related Publications (11)

• Augustin T, Burstein MD, Schneider EB, Morris-Stiff G, Wey J, Chalikonda S, Walsh RM. Frailty predicts risk of life-threatening complications and mortality after pancreatic resections. Surgery. 2016 Oct;160(4):987-996. doi: 10.1016/j.surg.2016.07.010. Epub 2016 Aug 18.

  PMID: 27545992 BACKGROUND

• Frassanito L, Giuri PP, Vassalli F, Piersanti A, Longo A, Zanfini BA, Catarci S, Fagotti A, Scambia G, Draisci G. Hypotension Prediction Index with non-invasive continuous arterial pressure waveforms (ClearSight): clinical performance in Gynaecologic Oncologic Surgery. J Clin Monit Comput. 2022 Oct;36(5):1325-1332. doi: 10.1007/s10877-021-00763-4. Epub 2021 Oct 7.

  PMID: 34618291 BACKGROUND

• Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

  PMID: 28973220 BACKGROUND

• Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.

  PMID: 29894315 BACKGROUND

• Pecorelli N, Capretti G, Sandini M, Damascelli A, Cristel G, De Cobelli F, Gianotti L, Zerbi A, Braga M. Impact of Sarcopenic Obesity on Failure to Rescue from Major Complications Following Pancreaticoduodenectomy for Cancer: Results from a Multicenter Study. Ann Surg Oncol. 2018 Jan;25(1):308-317. doi: 10.1245/s10434-017-6216-5. Epub 2017 Nov 7.

  PMID: 29116490 BACKGROUND

• Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.

  PMID: 27792044 BACKGROUND

• Schneck E, Schulte D, Habig L, Ruhrmann S, Edinger F, Markmann M, Habicher M, Rickert M, Koch C, Sander M. Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomised blinded prospective interventional trial. J Clin Monit Comput. 2020 Dec;34(6):1149-1158. doi: 10.1007/s10877-019-00433-6. Epub 2019 Nov 29.

  PMID: 31784852 BACKGROUND

• Solares GJ, Garcia D, Monge Garcia MI, Crespo C, Rabago JL, Iglesias F, Larraz E, Zubizarreta I, Rabanal JM. Real-world outcomes of the hypotension prediction index in the management of intraoperative hypotension during non-cardiac surgery: a retrospective clinical study. J Clin Monit Comput. 2023 Feb;37(1):211-220. doi: 10.1007/s10877-022-00881-7. Epub 2022 Jun 2.

  PMID: 35653007 BACKGROUND

• van der Ven WH, Veelo DP, Wijnberge M, van der Ster BJP, Vlaar APJ, Geerts BF. One of the first validations of an artificial intelligence algorithm for clinical use: The impact on intraoperative hypotension prediction and clinical decision-making. Surgery. 2021 Jun;169(6):1300-1303. doi: 10.1016/j.surg.2020.09.041. Epub 2020 Dec 11.

  PMID: 33309616 BACKGROUND

• Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.

  PMID: 30236233 BACKGROUND

• 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: 32065827 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Federico Piccioni

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesia section 1

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: May 23, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

IT (1)