Mini Fluid chAlleNge and End-expiratory Occlusion Test and to Assess flUid responsiVEness in opeRating Room

NCT03808753 | Completed

• 1 other identifier: MANEUVER_1
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

Brief Summary

End-expiratory occlusion test (EEOT) has been previously successfully tested in surgical patients, consisting of the interruption of the mechanical ventilation for 30 seconds, and in the evaluation of the changes in the SV. The mini fluid challenge test (mFC) aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC. Both these test have been previously evaluated in small-sized studies and never compared each other.

Conditions

Hemodynamic Instability; Anesthesia; Surgery

Keywords

Mini Fluid Challenge; End-expiratory occlusion test; Fluid responsiveness; Functional Hemodynamic Test

Outcome Measures

Primary Outcomes (1)

• ROC curve calculation

  Calculation of the area under the ROC curve considering the response to the fluid challenge test (considered as gold standard).

  10 minutes

Secondary Outcomes (1)

• ROC:Comparison of the areas under the ROC curve of each test (EEOT and mFC)

  10 minutes

Study Arms (1)

Treatment - hemodynamic tests: EEOT and mFC

EXPERIMENTAL

Interventions: all the enrolled patients will be tested using the EEOT and the mFC.

Diagnostic Test: End-expiratory occlusion test (EEOT); Other: mini fluid challenge (mFC)

Interventions

End-expiratory occlusion test (EEOT) DIAGNOSTIC_TEST

The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator.

Treatment - hemodynamic tests: EEOT and mFC

mini fluid challenge (mFC) OTHER

The mFC is performed by injecting a first aliquot of 100 ml of crystalloid over 1 minute before completing the 4 ml/kg-FC over the residual 9 minutes.

Treatment - hemodynamic tests: EEOT and mFC

Eligibility Criteria

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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (3)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Careggi University Hospital

Florence, Tuscany, 50134, Italy

Location

Maggiore della Carità University Hospital

Novara, 28100, Italy

Location

Related Publications (6)

• Messina A, Pelaia C, Bruni A, Garofalo E, Bonicolini E, Longhini F, Dellara E, Saderi L, Romagnoli S, Sotgiu G, Cecconi M, Navalesi P. Fluid Challenge During Anesthesia: A Systematic Review and Meta-analysis. Anesth Analg. 2018 Dec;127(6):1353-1364. doi: 10.1213/ANE.0000000000003834.

  PMID: 30300177 BACKGROUND

• Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.

  PMID: 25435480 BACKGROUND

• Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.

  PMID: 21792056 BACKGROUND

• Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

  PMID: 25392034 BACKGROUND

• Biais M, Larghi M, Henriot J, de Courson H, Sesay M, Nouette-Gaulain K. End-Expiratory Occlusion Test Predicts Fluid Responsiveness in Patients With Protective Ventilation in the Operating Room. Anesth Analg. 2017 Dec;125(6):1889-1895. doi: 10.1213/ANE.0000000000002322.

  PMID: 28742783 BACKGROUND

• Messina A, Lionetti G, Foti L, Bellotti E, Marcomini N, Cammarota G, Bennett V, Saderi L, Sotgiu G, Della Corte F, Protti A, Monge Garcia MI, Romagnoli S, Cecconi M. Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiVEness in the opeRating room (MANEUVER study): A multicentre cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):422-431. doi: 10.1097/EJA.0000000000001406.

  PMID: 33399372 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU senior consultant

Model Details: The study protocol was started during a period of intraoperative hemodynamic stability, as previously defined (i.e. change in mean arterial pressure of less than 10% during 5 minutes). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline ventilation of 7 ml/Kg and then the EEOT is performed by using the software function, "expiratory hold", to interrupt mechanical ventilation; 2) after one minute a set of measurements was recorded (T1); 3) the mFC is then performed; 4) a FC of overall 4 mL/Kg of crystalloid solution is infused over 9 minutes (T2). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment.

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: February 27, 2019
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

IT (3)