Hemodynamic InstabilityEXPIRENCT04399278
End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room (EXPIRE)
A study testing Diagnostic Test: end-expiratory occlusion (EEO) test in people with Hemodynamic Instability and General Anesthesia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, General Anesthesia, Surgery
- What is being tested?
- Diagnostic Test: end-expiratory occlusion (EEO) test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2020to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Body Mass Index <15 or > 40kg/m2
- Contraindication to insertion of invasive arterial line into radial artery
- Emergency surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Diagnostic Test: end-expiratory occlusion (EEO) test
- Keywords
- End-expiratory occlusion, Fluid responsiveness, Fluid Challenge, Intraoperative monitoring, Hemodynamic optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: end-expiratory occlusion (EEO) testDiagnostic 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.).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Diagnostic Test: Diagnostic Test: end-expiratory occlusion (EEO) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start3 Aug 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Futier, PhD, Study chair, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399278
- Sponsor's protocol ID
- EXPIRE - RBHP 2020 FUTIER
- Acronym
- EXPIRE
- Status last verified
- Aug 2021
- First submitted
- 19 May 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)
- ClinicalTrials.gov ID
- NCT04399278
- Acronym / sponsor ID
- EXPIRE / EXPIRE - RBHP 2020 FUTIER
- Keywords
- End-expiratory occlusion, Fluid responsiveness, Fluid Challenge, Intraoperative monitoring, Hemodynamic optimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Diagnostic Test: Diagnostic Test: end-expiratory occlusion (EEO) testThe EEO test will be applied first over 15 seconds and secondly over 30 seconds (each EEO test separated by 1 minute wash-out period) |
| Group B | Other | Diagnostic Test: Diagnostic Test: end-expiratory occlusion (EEO) testThe EEO test will be applied first over 30 seconds and secondly over 15 seconds (each EEO test separated by 1 minute wash-out period) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: end-expiratory occlusion (EEO) testA 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.). | Diagnostic test | Group A, Group B |
Primary outcome
To compare the ability of an EEO over 30 sec with that of an EEO over 15 sec to predict fluid responsiveness
Time frame: During surgery
Comparison of the areas under the ROC (Receiver Operating Characteristic) curves.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Futier, PhD study chair
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: end-expiratory occlusion (EEO) test in people with Hemodynamic Instability and General Anesthesia, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the ability of an EEO over 30 sec with that of an EEO over 15 sec to predict fluid responsiveness (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.