Ventricular-Arterial Coupling: A Predictor of Post-Induction Hypotension

NCT05969886 | Completed

• 2 other identifiers: 32/GCN-HDDDNo: 32/GCN-HDDD
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

Post-induction hypotension (PIH) is a common occurrence during the period from induction of general anesthesia to initiation of incision. PIH has been identified as an independent risk factor for postoperative major complications. Identifying high-risk patients for PIH could potentially help prevent its occurrence. Several risk factors associated with PIH have been identified, including patient conditions and use of specific anesthetic agents. Ventricular-arterial coupling (VAC) is evaluated using the ratio Ea/Ees and represents the interaction between the left ventricle (LV) and the arterial system. It reflects how changes in LV contractility (Ees) and changes in arterial load (Ea) work together to maintain optimal LV performance. A study aims to investigate the relationship between preoperative Ea/Ees ratio and the incidence of PIH (defined as MAP \< 65 mmHg).

Conditions

Hypotension on Induction

Keywords

Ventricular-Arterial Coupling (VAC); Ea/Ees ratio; Post-induction hypotension (PIH); Risk factors for PIH

Outcome Measures

Primary Outcomes (1)

• Prediction

  Investigate the predictive value of the Ea/Ees ratio (along with echocardiographic variables) on PIH.

  from induction of anesthesia to incision initiation

Secondary Outcomes (1)

• Incidence

  from induction of anesthesia to incision initiation

Eligibility Criteria

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

Study Population

Patients with American Society of Anesthesiologists (ASA) physical status 1 - 4 who underwent elective surgery

You may qualify if:

• Patients ≥ 18 years old.
• Patients with ASA (American Society of Anesthesiologists) physical status 1 - 4.
• Elective surgery.
• Preoperative transthoracic echocardiography was performed within 48 hours before surgery. The values of Ees and Ea were determined by the method of Chen.
• Patients consented to participate in the study.
• Patients scheduled for surgery undergoing standard general anesthesia (protocol: see below) with endotracheal intubation.
• Patients were hemodynamically stable until the preoperative period.

You may not qualify if:

• Cardiac and obstetric surgery.
• Allergy to any anesthetic drug.
• Arrhythmia.
• Severe valvular heart disease.
• Severe pre-existing lung disease.
• Mean pulmonary arterial pressure (PAPm ≥ 40 mmHg).
• Anticipation of difficult airway management.
• Hypotension occurs during the induction of anesthesia due to suspected anaphylaxis.

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Centre Ho Chi Minh

Ho Chi Minh City, Vietnam

Location

Related Publications (13)

• Yoshimura M, Shiramoto H, Koga M, Morimoto Y. Preoperative echocardiography predictive analytics for postinduction hypotension prediction. PLoS One. 2022 Nov 28;17(11):e0278140. doi: 10.1371/journal.pone.0278140. eCollection 2022.

  PMID: 36441797 RESULT

• Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.

  PMID: 30144029 RESULT

• Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.

  PMID: 28974066 RESULT

• Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255.

  PMID: 34859868 RESULT

• Tarao K, Daimon M, Son K, Nakanishi K, Nakao T, Suwazono Y, Isono S. Risk factors including preoperative echocardiographic parameters for post-induction hypotension in general anesthesia. J Cardiol. 2021 Sep;78(3):230-236. doi: 10.1016/j.jjcc.2021.03.010. Epub 2021 Apr 8.

  PMID: 33838982 RESULT

• Monge Garcia MI, Santos A. Understanding ventriculo-arterial coupling. Ann Transl Med. 2020 Jun;8(12):795. doi: 10.21037/atm.2020.04.10.

  PMID: 32647720 RESULT

• Guinot PG, Andrei S, Longrois D. Ventriculo-arterial coupling: from physiological concept to clinical application in peri-operative care and ICUs. Eur J Anaesthesiol Intensive Care. 2022 Aug 3;1(2):e004. doi: 10.1097/EA9.0000000000000004. eCollection 2022 Apr.

  PMID: 39916686 RESULT

• Aktas Yildirim S, Sarikaya ZT, Dogan L, Ulugol H, Gucyetmez B, Toraman F. Arterial Elastance: A Predictor of Hypotension Due to Anesthesia Induction. J Clin Med. 2023 Apr 27;12(9):3155. doi: 10.3390/jcm12093155.

  PMID: 37176595 RESULT

• Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.

  PMID: 11738311 RESULT

• Mitchell C, Rahko PS, Blauwet LA, Canaday B, Finstuen JA, Foster MC, Horton K, Ogunyankin KO, Palma RA, Velazquez EJ. Guidelines for Performing a Comprehensive Transthoracic Echocardiographic Examination in Adults: Recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2019 Jan;32(1):1-64. doi: 10.1016/j.echo.2018.06.004. Epub 2018 Oct 1. No abstract available.

  PMID: 30282592 RESULT

• Cho JY, Kim KH. Evaluation of Arterial Stiffness by Echocardiography: Methodological Aspects. Chonnam Med J. 2016 May;52(2):101-6. doi: 10.4068/cmj.2016.52.2.101. Epub 2016 May 20.

  PMID: 27231673 RESULT

• Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

  PMID: 16571963 RESULT

• Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.

  PMID: 18337600 RESULT

Study Officials

• Khoi M Le, Assoc.Prof

  University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: July 3, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 10, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the study. Indefinitely
• Access Criteria: "Data will be shared upon reasonable request, with approval based on the researcher's qualifications and the purpose of the request." Access will only be granted to academic or non-commercial researchers who meet the conditions outlined in the Data Use Agreement.

Locations

VN (1)