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

NCT04399278 | Completed

• 1 other identifier: EXPIRE - RBHP 2020 FUTIER
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Instability; General Anesthesia; Surgery; Protective Mechanical Ventilation

Keywords

End-expiratory occlusion; Fluid responsiveness; Fluid Challenge; Intraoperative monitoring; Hemodynamic optimization

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

OTHER

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

Group B

OTHER

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

Interventions

Diagnostic Test: end-expiratory occlusion (EEO) test DIAGNOSTIC_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.).

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

Location

Study Officials

• Emmanuel Futier, PhD

  University Hospital, Clermont-Ferrand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization sequence by permuted blocks (random block sizes) with an allocation of 1:1 will be generated by a computer program (Stata software, version 15, StataCorp, College Station, US) The group assignment will be concealed until arrival in the operating room so that only the anesthesiologist in charge of the patient will aware to the randomization group
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 and 30 seconds using the end-expiratory hold button available on the anesthesia ventilator. Each occlusion will be separated by 1 minute to allow a return to the baseline value. Hemodynamic variables will be recorded before and immediately after each EEO procedure, and after a fluid challenge (4 ml/kg of 0.9% saline over 5 minutes). Fluid responders will be defined by an increase in stroke volume ≥15% 1 min after the end of the fluid challenge.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: August 3, 2020
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

FR (1)