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

Humanitas Clinical and Research Center

Status

Completed

Conditions

Hemodynamic Instability

Surgery

Anesthesia

Treatments

Other: mini fluid challenge (mFC)

Diagnostic Test: End-expiratory occlusion test (EEOT)

Study type

Interventional

Funder types

Other

Identifiers

NCT03808753

MANEUVER_1

Details and patient eligibility

About

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.

Full description

Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload [1]. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients [2-10].

Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) [11-13] and this effect is obtained only in about 50% of ICU and OR patients [14, 15], a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging [1, 13, 16-18]. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness [17]. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume (SV) variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients [19-22].

To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity [17, 18, 23]. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent [17, 18, 23].

The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 [24] and its reliability has been confirmed by three large meta-analyses [25-27]. However, the PLR is not usually practicable in the OR.

A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV [24, 28]. Among these tests, the 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. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC [29, 30]. This test is called mini fluid challenge (mFC). Both these test have been previously evaluated in small-sized studies and never compared each other.

The primary aim of the present study is to compare the reliability of EEOT and mFC in predicting fluid responsiveness in patients undergoing general surgery.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

All elective adults (age > 18 years) consecutive patients scheduled for elective abdominal surgery requiring invasive arterial monitoring and scheduled in those operating rooms equipped with ventilators having an expiratory-hold function.

The preoperative exclusion criteria were 1) any recurrent cardiac arrhythmia; 2) known reduced left (ejection fraction < 30%) or right (systolic peak velocity of tricuspid annular motion < 0.17 m/s) ventricular systolic function; Body Mass Index > 35; 4) chronic obstructive pulmonary disease classified as GOLD ≥ 2. Once enrolled, the patient can be additionally excluded because of the occurrence of one of the following intraoperative conditions: 1) significant bleeding (more than 500 ml in ½ hour); 2) persistent and/or recurrent extrasystoles; 3) persistent low quality of the arterial signal despite optimization of the signal (see further).