Clinical trial NCT03820440: End-expiratory Occlusion Test and Lung Recruitment Maneuver to Assess Fluid responsiVeness In Surgical Patients
Official title: End-expiratory Occlusion Test and Lung Recruitment Maneuver to Assess Fluid responsiVeness In Surgical Patients: an Open-label, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodynamic Instability
Surgery
Fluid Overload
Keywords: End-expiratory occlusion test
Lung Recruitment Manovre
Fluid responsiveness
Functional Hemodynamic Test
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2019-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (change in mean arterial pressure of less than 10% during 5 minutes). The study protocol is the following: 1) a set of measurements is 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 LRM is then performed; 4) after one minute another set of measurements is recorded (T2) and then a fluid challenge of 4 mL/Kg of crystalloid solution is infused over 10 minutes. The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment. The sequence of application of EEOT and LRM on the same patient (EEOT_LRM or LRM_EEOT) is randomly generated.
Primary purpose: DIAGNOSTIC

Brief summary: The functional hemodynamic test (FHT) called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. 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. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC.

Among the first group, the end-expiratory occlusion test (EEOT) and the lung recruitment maneuver (LRM) have been previously successfully tested in surgical patients. The EEOT consists of the interruption of the mechanical ventilation for 30 seconds, whereas the LRM consists in the increase in the peak inspiratory pressure up to 30 cmH20 for 30 seconds and in the assessment of the changes in the SV after the maneuvers. These tests are safe and can be easily applicable during the surgery to predict fluid responsiveness and optimize the fluid therapy.

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

Detailed 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 \[pulse pressure variation (PPV) and stroke volume variation (SVV), respectively\], 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 \[24, 28\]. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC \[29, 30\].

Among the first group, the end-expiratory occlusion test (EEOT) and the lung recruitment maneuver (LRM) have been previously successfully tested in surgical patients \[31-33\]. The EEOT consists of the interruption of the mechanical ventilation for 30 seconds, whereas the LRM consists in the increase in the peak inspiratory pressure up to 30 cmH20 for 30 seconds and in the assessment of the changes in the SV after the maneuvers. These tests are safe and can be easily applicable during the surgery to predict fluid responsiveness and optimize the fluid therapy.

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

(for Bibliography please refer to the original protocol)

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged ≥ 18 years;
2. Scheduled for elective supine abdominal surgery and requiring invasive arterial monitoring;
3. Glasgow coma scale 15 at recruitment. All the patients must be able to sign an informed consent at the admission.

Exclusion Criteria:

1. Any recurrent cardiac arrhythmias;
2. Reduced left (ejection fraction \<30%) or right (systolic peak velocity of tricuspid annular motion \<0.17 m/s) ventricular systolic function;
3. Chronic use beta-blocking agents.
4. History of pneumothorax.
5. BMI \> 40

Primary outcomes:
measure: AUC difference
timeFrame: 10 minutes after fluid challenge administration
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: 10 minutes after fluid challenge administration
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milano
Study officials:
References:
citation: 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.
citation: Biais M, Lanchon R, Sesay M, Le Gall L, Pereira B, Futier E, Nouette-Gaulain K. Changes in Stroke Volume Induced by Lung Recruitment Maneuver Predict Fluid Responsiveness in Mechanically Ventilated Patients in the Operating Room. Anesthesiology. 2017 Feb;126(2):260-267. doi: 10.1097/ALN.0000000000001459.