Fluid Responsiveness: SVV vs esSVV in Mechanically Ventilated and Spontaneously Breathing Patients

NCT04786652 | Completed

• 1 other identifier: 2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative period after off-pump coronary artery bypass grafting (OPCAB) can be a challenging area for emerging methods for less-invasive continuous hemodynamic monitoring. The primary goal of this study is to assess the accuracy of estimated stroke volume variation (esSVV, Nihon Kohden, Japan) compared with SVV determined by conventional pulse contour analysis (SVVPCA), respectively. All the measurements and tests will be performed:

1. 1.In mechanically ventilated patients after OPCAB within two hrs after intervention: passive leg raising (PLR), increased PEEP, and mini-fluid load (mFL) tests will be followed by standard fluid load (sFL). Monitoring: SVVPCA, PPVPCA, esSVV, HLI, PVI, pre-ejection fraction (PEP, echocardiography), CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase (PEP).
2. 2.In spontaneously breathing patients at 18 hrs of the postoperative period: PLR, and mFL tests followed by sFL. Monitoring: SVVPCA, PPVPCA, esSVV, PVI, PEP, CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase.

Conditions

Hemodynamic Instability; Postoperative Complications

Keywords

cardiac surgery; fluid responsiveness; dynamic tests

Outcome Measures

Primary Outcomes (1)

• Accuracy of estimated stroke volume variation

  The primary goal of this study is to assess the accuracy of estimated stroke volume variation (esSVV, Nihon Kohden, Japan) compared with SVV determined by conventional pulse contour analysis (SVVPCA), respectively.

  immediately postoperatively

Secondary Outcomes (1)

• Predictive value of esSVV

  immediately postoperatively

Study Arms (1)

Assessment of fluid responsiveness

EXPERIMENTAL

Device: estimated stroke volume variation (esSVV, Nihon Kohden, Japan); Diagnostic Test: Assessment of fluid responsiveness in mechanically ventilated patients after OPCAB; Diagnostic Test: Assessment of fluid responsiveness in spontaneously breathing patients at 18 hrs of the postoperative period

Interventions

estimated stroke volume variation (esSVV, Nihon Kohden, Japan) DEVICE

Assessment of the estimated stroke volume variation (esSVV, Nihon Kohden, Japan) in the early postoperative period after OPCAB

Assessment of fluid responsiveness

Assessment of fluid responsiveness in mechanically ventilated patients after OPCAB DIAGNOSTIC_TEST

In mechanically ventilated patients after OPCAB within two hrs after intervention: passive leg raising (PLR), increased PEEP, and mini-fluid load (mFL) tests will be followed by standard fluid load (sFL). Monitoring: SVVPCA, PPVPCA, esSVV, HLI, PVI, pre-ejection fraction (PEP, echocardiography), CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase (PEP).

Assessment of fluid responsiveness

Assessment of fluid responsiveness in spontaneously breathing patients at 18 hrs of the postoperative period DIAGNOSTIC_TEST

2\) In spontaneously breathing patients at 18 hrs of the postoperative period: PLR, and mFL tests followed by sFL. Monitoring: SVVPCA, PPVPCA, esSVV, PVI, PEP, CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase.

Assessment of fluid responsiveness

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective off-pump coronary arteries bypass grafting.
• Age \> 18 years and \< 80 yrs.
• Preoperative echocardiographic ejection fraction \> 0.35

You may not qualify if:

• Simultaneous operation (carotid endarterectomy, valve repair, aneurysm resection, etc.).
• Significant peripheral arteriopathy.
• Constant form of atrial fibrillation.
• Pacemaker
• Severe valve dysfunction.
• The surgical requirement to harvest both radial arteries.
• Intra-aortic balloon pump.
• Transfer to cardiopulmonary bypass (on-pump CABG).

Sponsors & Collaborators

• Northern State Medical University: lead
• Nihon Kohden: collaborator

Study Sites (1)

City hospital # 1 / Northern State Medical University,

Arkhangelsk, 163001, Russia

Location

Related Publications (3)

• Smetkin AA, Kirov MY, Kuzkov VV, Lenkin AI, Eremeev AV, Slastilin VY, Borodin VV, Bjertnaes LJ. Single transpulmonary thermodilution and continuous monitoring of central venous oxygen saturation during off-pump coronary surgery. Acta Anaesthesiol Scand. 2009 Apr;53(4):505-14. doi: 10.1111/j.1399-6576.2008.01855.x. Epub 2009 Jan 15.

  PMID: 19183113 BACKGROUND

• Kirov MY, Lenkin AI, Kuzkov VV, Suborov EV, Slastilin VY, Borodin VV, Chernov II, Shonbin AN, Bjertnaes LJ. Single transpulmonary thermodilution in off-pump coronary artery bypass grafting: haemodynamic changes and effects of different anaesthetic techniques. Acta Anaesthesiol Scand. 2007 Apr;51(4):426-33. doi: 10.1111/j.1399-6576.2006.01247.x.

  PMID: 17378780 BACKGROUND

• Smetkin AA, Hussain A, Fot EV, Zakharov VI, Izotova NN, Yudina AS, Dityateva ZA, Gromova YV, Kuzkov VV, Bjertnaes LJ, Kirov MY. Estimated continuous cardiac output based on pulse wave transit time in off-pump coronary artery bypass grafting: a comparison with transpulmonary thermodilution. J Clin Monit Comput. 2017 Apr;31(2):361-370. doi: 10.1007/s10877-016-9853-5. Epub 2016 Mar 7.

  PMID: 26951494 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: March 20, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)