Hemodynamic InstabilityMANEUVERNCT03808753
Mini Fluid chAlleNge and End-expiratory Occlusion Test and to Assess flUid responsiVEness in opeRating Room
A study testing End-expiratory occlusion test (EEOT) and mini fluid challenge (mFC) in people with Hemodynamic Instability and Anesthesia, run by Humanitas Clinical and Research Center at 3 sites in Italy.
Trial summary
End-expiratory occlusion test (EEOT) has been previously successfully tested in surgical patients, consisting of the interruption of the mechanical ventilation for 30 seconds, and in the evaluation of the changes in the SV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Anesthesia, Surgery
- What is being tested?
- End-expiratory occlusion test (EEOT) and mini fluid challenge (mFC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 3 sitesItaly
- Study dates
- 27 Feb 2019to 16 Jan 2020
- 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
All elective adults (age > 18 years) consecutive patients scheduled for elective abdominal surgery requiring invasive arterial monitoring and scheduled in those operating rooms equipped with ventilators having an expiratory-hold function.
The preoperative exclusion criteria were 1) any recurrent cardiac arrhythmia; 2) known reduced left (ejection fraction < 30%) or right (systolic peak velocity of tricuspid annular motion < 0.17 m/s) ventricular systolic function; Body Mass Index > 35; 4) chronic obstructive pulmonary disease classified as GOLD ≥ 2. Once enrolled, the patient can be additionally excluded because of the occurrence of one of the following intraoperative conditions: 1) significant bleeding (more than 500 ml in ½ hour); 2) persistent and/or recurrent extrasystoles; 3) persistent low quality of the arterial signal despite optimization of the signal (see further).
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Careggi University Hospital
Florence, Tuscany, 50134
Maggiore della Carità University Hospital
Novara, 28100
Humanitas Research Hospital
Rozzano, Milano, 20089
About this study
Official title: Mini Fluid chAlleNge and End-expiratory Occlusion Test and to Assess flUid responsiVEness in opeRating Room: an Open-label, Randomized Clinical Trial
End-expiratory occlusion test (EEOT) has been previously successfully tested in surgical patients, consisting of the interruption of the mechanical ventilation for 30 seconds, and in the evaluation of the changes in the SV.
The mini fluid challenge test (mFC) aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC.
Both these test have been previously evaluated in small-sized studies and never compared each other.
Read the detailed description
Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload [1]. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients [2-10].
Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) [11-13] and this effect is obtained only in about 50% of ICU and OR patients [14, 15], a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging [1, 13, 16-18]. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness [17]. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume (SV) variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients [19-22].
To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity [17, 18, 23]. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent [17, 18, 23].
The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 [24] and its reliability has been confirmed by three large meta-analyses [25-27]. However, the PLR is not usually practicable in the OR.
A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV [24, 28]. Among these tests, the end-expiratory occlusion test (EEOT) has been previously successfully tested in surgical patients, consisting of the interruption of the mechanical ventilation for 30 seconds, and in the evaluation of the changes in the SV. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC [29, 30]. This test is called mini fluid challenge (mFC). Both these test have been previously evaluated in small-sized studies and never compared each other.
The primary aim of the present study is to compare the reliability of EEOT and mFC in predicting fluid responsiveness in patients undergoing general surgery.
- Conditions
- Hemodynamic Instability, Anesthesia, Surgery
- Being tested
- End-expiratory occlusion test (EEOT), mini fluid challenge (mFC)
- Keywords
- Mini Fluid Challenge, End-expiratory occlusion test, Fluid responsiveness, Functional Hemodynamic Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-expiratory occlusion test (EEOT)Diagnostic test
The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator.
mini fluid challenge (mFC)Other
The mFC is performed by injecting a first aliquot of 100 ml of crystalloid over 1 minute before completing the 4 ml/kg-FC over the residual 9 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - hemodynamic tests: EEOT and mFC | Experimental | Interventions: all the enrolled patients will be tested using the EEOT and the mFC. Receives: Diagnostic Test: End-expiratory occlusion test (EEOT); Other: mini fluid challenge (mFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curve calculation
Calculation of the area under the ROC curve considering the response to the fluid challenge test (considered as gold standard).
Measured: 10 minutes
Secondary outcomes (1)
ROC:Comparison of the areas under the ROC curve of each test (EEOT and mFC)
Comparison of the areas under the ROC curve of each test (EEOT and mFC)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start27 Feb 2019
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study protocol was 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). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline ventilation of 7 ml/Kg and then the EEOT is performed by using the software function, "expiratory hold", to interrupt mechanical ventilation; 2) after one minute a set of measurements was recorded (T1); 3) the mFC is then performed; 4) a FC of overall 4 mL/Kg of crystalloid solution is infused over 9 minutes (T2). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Messina, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808753
- Sponsor's protocol ID
- MANEUVER_1
- Acronym
- MANEUVER
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Messina A, Pelaia C, Bruni A, Garofalo E, Bonicolini E, Longhini F, Dellara E, Saderi L, Romagnoli S, Sotgiu G, Cecconi M, Navalesi P. Fluid Challenge During Anesthesia: A Systematic Review and Meta-analysis. Anesth Analg. 2018 Dec;127(6):1353-1364. doi: 10.1213/ANE.0000000000003834.
PubMed 30300177Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.
PubMed 25435480Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.
PubMed 21792056Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.
PubMed 25392034Biais M, Larghi M, Henriot J, de Courson H, Sesay M, Nouette-Gaulain K. End-Expiratory Occlusion Test Predicts Fluid Responsiveness in Patients With Protective Ventilation in the Operating Room. Anesth Analg. 2017 Dec;125(6):1889-1895. doi: 10.1213/ANE.0000000000002322.
PubMed 28742783Messina A, Lionetti G, Foti L, Bellotti E, Marcomini N, Cammarota G, Bennett V, Saderi L, Sotgiu G, Della Corte F, Protti A, Monge Garcia MI, Romagnoli S, Cecconi M. Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiVEness in the opeRating room (MANEUVER study): A multicentre cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):422-431. doi: 10.1097/EJA.0000000000001406.
PubMed 33399372
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Fluid chAlleNge and End-expiratory Occlusion Test and to Assess flUid responsiVEness in opeRating Room: an Open-label, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03808753
- Acronym / sponsor ID
- MANEUVER / MANEUVER_1
- Conditions
- Hemodynamic Instability, Anesthesia, Surgery
- Keywords
- Mini Fluid Challenge, End-expiratory occlusion test, Fluid responsiveness, Functional Hemodynamic Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 18 Jan 2019 (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.
End-expiratory occlusion test (EEOT) has been previously successfully tested in surgical patients, consisting of the interruption of the mechanical ventilation for 30 seconds, and in the evaluation of the changes in the SV.
The mini fluid challenge test (mFC) aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC.
Both these test have been previously evaluated in small-sized studies and never compared each other.
Detailed description
Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload [1]. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients [2-10].
Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) [11-13] and this effect is obtained only in about 50% of ICU and OR patients [14, 15], a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging [1, 13, 16-18]. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness [17]. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume (SV) variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients [19-22].
To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity [17, 18, 23]. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent [17, 18, 23].
The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 [24] and its reliability has been confirmed by three large meta-analyses [25-27]. However, the PLR is not usually practicable in the OR.
A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV [24, 28]. Among these tests, the end-expiratory occlusion test (EEOT) has been previously successfully tested in surgical patients, consisting of the interruption of the mechanical ventilation for 30 seconds, and in the evaluation of the changes in the SV. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC [29, 30]. This test is called mini fluid challenge (mFC). Both these test have been previously evaluated in small-sized studies and never compared each other.
The primary aim of the present study is to compare the reliability of EEOT and mFC in predicting fluid responsiveness in patients undergoing general surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study protocol was 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). The study protocol is was the following: 1) a set of measurements was recorded (T0) at a baseline ventilation of 7 ml/Kg and then the EEOT is performed by using the software function, "expiratory hold", to interrupt mechanical ventilation; 2) after one minute a set of measurements was recorded (T1); 3) the mFC is then performed; 4) a FC of overall 4 mL/Kg of crystalloid solution is infused over 9 minutes (T2). The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment - hemodynamic tests: EEOT and mFC | Experimental | Diagnostic Test: End-expiratory occlusion test (EEOT), Other: mini fluid challenge (mFC)Interventions: all the enrolled patients will be tested using the EEOT and the mFC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| End-expiratory occlusion test (EEOT)The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator. | Diagnostic test | Treatment - hemodynamic tests: EEOT and mFC |
| mini fluid challenge (mFC)The mFC is performed by injecting a first aliquot of 100 ml of crystalloid over 1 minute before completing the 4 ml/kg-FC over the residual 9 minutes. | Other | Treatment - hemodynamic tests: EEOT and mFC |
Primary outcome
ROC curve calculation
Time frame: 10 minutes
Calculation of the area under the ROC curve considering the response to the fluid challenge test (considered as gold standard).
1 secondary outcome
ROC:Comparison of the areas under the ROC curve of each test (EEOT and mFC)
Time frame: 10 minutes
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 18 Jan 2020.
- Background: PubMed 30300177Messina A, Pelaia C, Bruni A, Garofalo E, Bonicolini E, Longhini F, Dellara E, Saderi L, Romagnoli S, Sotgiu G, Cecconi M, Navalesi P. Fluid Challenge During Anesthesia: A Systematic Review and Meta-analysis. Anesth Analg. 2018 Dec;127(6):1353-1364. doi: 10.1213/ANE.0000000000003834.
- Background: PubMed 25435480Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.
- Background: PubMed 21792056Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.
- Background: PubMed 25392034Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.
- Background: PubMed 28742783Biais M, Larghi M, Henriot J, de Courson H, Sesay M, Nouette-Gaulain K. End-Expiratory Occlusion Test Predicts Fluid Responsiveness in Patients With Protective Ventilation in the Operating Room. Anesth Analg. 2017 Dec;125(6):1889-1895. doi: 10.1213/ANE.0000000000002322.
- Derived from this study: PubMed 33399372Messina A, Lionetti G, Foti L, Bellotti E, Marcomini N, Cammarota G, Bennett V, Saderi L, Sotgiu G, Della Corte F, Protti A, Monge Garcia MI, Romagnoli S, Cecconi M. Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiVEness in the opeRating room (MANEUVER study): A multicentre cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):422-431. doi: 10.1097/EJA.0000000000001406.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-expiratory occlusion test (EEOT) and mini fluid challenge (mFC) in people with Hemodynamic Instability and Anesthesia, run by Humanitas Clinical and Research Center at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
ROC curve calculation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808753, which also lists 6 linked publications.
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 18 Jan 2020.