Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHumanitas Clinical and Research Center

About this trial

Personalzing intraoperative anesthetic fluid management may help in preventing fluid accumulation and related complications.

Fluids are gine as boluses in operating room (the so-called FC). The response to the FC is due to several physiological conditions related to the "preload dependency" (i.e. the intrinsic ability of the heart of increasing the stroke volume - SV - in response to fluid administration).

The minimal volume required to appropriately "challenge" the cardiovascular system is 4 ml/kg of fluid, but higher volumes (up to 6 ml/kg may be needed).

Predicting the response to FC administration may be possible by applying a physiological test (called functional hemodynamic test), such as the end-expiratory occlusion test, consisting in interrupping the mechanical ventilation and hence promoting venous return and consequente SV changes. The percentage of SV increase associated to EEOT may predict fluid responsiveness to the FC (patients responders will increase SV to a bigger extent, as compared to non-responders)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged ≥ 18 years

Scheduled for elective supine abdominal laparotomic or neuro surgery, requiring invasive arterial monitoring and continuous hemodynamic monitoring

All the patients must be able to sign an informed consent at the admission

Disqualifiers

Any recurrent cardiac arrhythmias

Reduced left (ejection fraction <30%) or right (systolic peak velocity of tricuspid annular motion <0.17 m/s) ventricular systolic function

Urgent / Emergent surgery

Liver surgery

Trial population

Elective abdominal or neuro surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • fluid challenge

    Other intervention

    The study protocol is 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 \[32, 33\]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL/Kg of crystalloid solution is infused over 10 minutes (T4 end of the FC). 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 protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed. The mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M

  • end-expiratory occlusion test

    Diagnostic test

    The study protocol is 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 \[32, 33\]). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline 2) (T1) after one minute the EEOT is then performed by stopping the mechanical ventilation for 30 seconds (T2 - end of the EEOT test); 3) (T3) a FC of overall 6 mL/Kg of crystalloid solution is infused over 10 minutes (T4 end of the FC). 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 protocol is entirely intraoperative and data collections ends after FC administration. No follow-up is needed. The mentioned timepoints T0 - T1 - T2, corresponding to intrapeortive data recording points are also the endpoints of the study. At each specific timepoint, a marker is added to the M

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Group 12 interventions

Trial outcomes

Primary outcomes

1

fluid responsiveness

stroke volume index \> or equal to 10%

Time frame
10 minutes

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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