End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room (EXPIRE) (EXPIRE)

End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)

The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.

Study Overview

• Status: Completed
• Conditions: Surgery; General Anesthesia; Hemodynamic Instability; Protective Mechanical Ventilation
• Intervention / Treatment: Diagnostic test: Diagnostic Test: end-expiratory occlusion (EEO) test

Detailed Description

The reduction of postoperative complications is an essential aspect of care in perioperative medicine.

Many studies have shown that individualized hemodynamic therapy, by optimizing fluid administration and cardiac output, can reduce the risk of postoperative morbidity and mortality.

A fluid challenge, consisting in the administration of a small bolus of intravenous volume of fluid over a short period of time, is one of the commonest therapeutic hemodynamic intervention to test the preload reserve and the cardiac response to an increase in intravascular volume of a patient (fluid responsiveness). However, an increase in stroke volume (or cardiac output) is only achieved in 30 to 50% of patients after a fluid challenge test. Several dynamic tests have been described to predict the response to fluid challenge, however their limits are numerous.

The end-expiratory occlusion (EEO) test, consisting in a brief interruption of mechanical ventilation at end-expiration, by preventing the variation in intra-thoracic pressure, allows an increase in venous return, cardiac preload and stroke volume. Thus, an increase in stroke volume during an EEO can predict fluid responsiveness, simulating a fluid challenge though avoiding the administration of possibly unnecessary fluids.

The EEO test has already been successfully evaluated in several studies in ICU patients. Only few studies were conducted in the operating room, with conflicting findings: one study, consisting of an EEO test of 30 seconds found that changes in stroke volume during an EEO can predict fluid responsiveness, whereas another one, consisting of an EEO test of 15 seconds did not.

The purpose of the study is to evaluate the influence of the duration of EEO test to predict fluid responsiveness in mechanically ventilated patients in operating room.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (age >18 years)
• Scheduled to undergo planned surgery under general anesthesia
• Surgery requiring invasive arterial and stroke volume monitoring
• Clinical indication to perform a fluid challenge
• Patients able to give informed consent
• Affiliated to a social security scheme

Exclusion Criteria:

• Patient refusal to participate or inability to provide informed consent
• Protected major
• History of lobectomy or pneumectomy
• Patient with reduced left (ejection fraction < 45%) or right ventricular systolic function
• Arrythmia
• Severe valvulopathy
• Body Mass Index <15 or > 40kg/m2
• Contraindication to insertion of invasive arterial line into radial artery
• Emergency surgery
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; The EEO test will be applied first over 15 seconds and secondly over 30 seconds (each EEO test separated by 1 minute wash-out period)	Diagnostic test: Diagnostic Test: end-expiratory occlusion (EEO) test; A set of respiratory and hemodynamic measurements (including cardiac output) will be recorded at each stage: T0: baseline.; T1: At the end of the first EEO (15 sec or 30 sec); T2: 1 minute after completion of the first EEO. Return to baseline.; T3: At the end of the second EEO (15 sec or 30 sec); T4: 1 minute after completion of the second EEO. Return to baseline.; T5: Before the fluid challenge test (4 ml/kg of 0.9% saline over 5 min); T6: 1 minute after the end of the fluid challenge A first set of measurements will be performed after intubation (before the surgical incision) and will be repeated, if necessary, in case of further decrease in stroke volume during surgery or in case of any clinical indication of volume expansion (i.e., arterial persistent hypotension, major hemorrhage, etc.).
Other: Group B; The EEO test will be applied first over 30 seconds and secondly over 15 seconds (each EEO test separated by 1 minute wash-out period)	Diagnostic test: Diagnostic Test: end-expiratory occlusion (EEO) test; A set of respiratory and hemodynamic measurements (including cardiac output) will be recorded at each stage: T0: baseline.; T1: At the end of the first EEO (15 sec or 30 sec); T2: 1 minute after completion of the first EEO. Return to baseline.; T3: At the end of the second EEO (15 sec or 30 sec); T4: 1 minute after completion of the second EEO. Return to baseline.; T5: Before the fluid challenge test (4 ml/kg of 0.9% saline over 5 min); T6: 1 minute after the end of the fluid challenge A first set of measurements will be performed after intubation (before the surgical incision) and will be repeated, if necessary, in case of further decrease in stroke volume during surgery or in case of any clinical indication of volume expansion (i.e., arterial persistent hypotension, major hemorrhage, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the ability of an EEO over 30 sec with that of an EEO over 15 sec to predict fluid responsiveness	Comparison of the areas under the ROC (Receiver Operating Characteristic) curves.	During surgery

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Study Chair: Emmanuel Futier, PhD, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Fluid responsiveness; Fluid Challenge; Hemodynamic optimization; Intraoperative monitoring; End-expiratory occlusion
• Other Study ID Numbers: EXPIRE - RBHP 2020 FUTIER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No