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

NCT06627907 | Not Yet Recruiting

• 1 other identifier: FC_EEOT
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Fluid Responsiveness Predictability

Keywords

Fluid challenge; End-expiratory occlusion test; FLuid responsiveness; Surgery

Outcome Measures

Primary Outcomes (1)

• fluid responsiveness

  stroke volume index \> or equal to 10%

  10 minutes

Study Arms (1)

Group 1

Patients receiving a fluid challenge

Other: fluid challenge; Diagnostic Test: end-expiratory occlusion test

Interventions

fluid challenge OTHER

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

Group 1

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

Group 1

Eligibility Criteria

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

Study Population

Elective abdominal or neuro surgery

You may qualify if:

• 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

You may not qualify if:

• 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
• Laparoscopic surgery

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Central Study Contacts

Antonio Messina, PhD

CONTACT

+390282241; antonio.messina@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10