WeaningPoEMNCT05358405
Prediction Of Pulmonary Edema With Müller Maneuver
A study testing Müller maneuver in people with Weaning and Spontaneous Breathing Trial, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient. However, some patients fail this test and cannot be extubated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, Spontaneous Breathing Trial
- What is being tested?
- Müller maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 9 Jul 2024
- 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
- Men and women over 18 years old ;
- With health insurance ;
- Placed under mechanical ventilation for at least 24 hours ;
- Conscious patient.
Who cannot join
- Pregnancy (blood assay of βHCG) ;
- Participation in another intervention study ;
- Patient with chest tube
- Tracheostomy ;
- Patient under legal protection ;
- Patient receiving state medical assistance (AME).
Trial locations and contacts
1 site in 1 country.
About this study
The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient.
However, some patients fail this test and cannot be extubated. The main causes are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible. To assess the risk of pulmonary edema, cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, can be estimated using simple tests as the passive leg raising test before an SBT.
Read more
However, this test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care.
The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice.
The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation.
The study consist in the measurement of cardiac output before and after the passive leg raising test and the Müller maneuver, then measurement of cardiac output before and after an SBT.
A transthoracic ultrasound and a blood sample with dosage of proteins and hemoglobin will be carried out initially and then at the end of the SBT as part of routine care.
The investigators hypothesize:
- The Müller maneuver induces a greater increase in cardiac output in patients in a state of preload dependancy than in patients in a state of preload independancy.
- The absence of documented preload dependancy during a Müller maneuver is associated with the occurrence of pulmonary edema during an SBT.
The investigators included patients :
- > 18 years old, conscious patient, with health insurance, placed under mechanical ventilation for at least 24 hours ;
- In whom it was decided to perform a passive leg raising test and an SBT. The investigators excluded pregnancy, patient with chest tube, particpation in another interventional study, tracheostomy, patient under legal protection.
Read the detailed description
The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient. The main causes of weaning failure are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible.
To predict the risk of pulmonary edema, physician could 1/ estimate the cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, using simple tests as the passive leg raising test before an SBT. This test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care 2/ measure the hemoconcentration (hemoglobin and protein variation before and after SBT). However, this tests are not easy in intensive care unit.
The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice.
The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation. The investigators include patients:
- Placed under mechanical ventilation for at least 24 hours ;
- In whom it was decided to perform a leg lift test and an SBT. Patients are intubated and ventilated on the ventilators of the intensive care unit (v500, Dräger Medical, Lübeck, Germany or Carescape r860, GE Healthcare, Buc, France). The initial settings are decided by the physician in charge of the patient according to the gas exchanges.
The passive leg raising test consists of transferring a patient from a semi-sitting position to a position in which the trunk is horizontal and the lower limbs are elevated at 45°. This is achieved by the electrically operated bed. The test is considered positive (preload dependency) if the cardiac output increases more than 10%. This test is performed in common practice to assess the cardiac preload of patients before an SBT. The cardiac output is measured by transpulmonary thermodilution (if the patient is equiped by this dispositif before the study) or by cardiac echography.
SBT consists of reproducing the ventilation conditions once the patient has been extubated. This test is carried out using a so-called "T" piece connected to the end of the intubation tube or by canceling the assistance of the ventilator during 30 minutes. This test is performed daily in intensive care in the intubated patient before any extubation.The determination of hemoglobin and plasma proteins consists of a blood sample via a catheter already in place and its analysis before and after the SBT. An increase in hemoglobin or plasmatique proteins by 6% detect a weaning pulmonary edema .
The acts/procedures added by the search are:
- Transthoracic ultrasound added for research if the monitoring system PiCCO2 is not set up in the patient as part of the treatment. Transthoracic echocardiography is a medical imaging technique based on the use of ultrasound, inaudible, painless and harmless sound waves that allow visualization of the cardiac silhouette, its functioning and allows measurement of cardiac output, fraction ventricular ejection and other diagnostic parameters for left heart failure and pulmonary edema (E/A and E/e' ratios). This technique is used in routine daily practice by physicians in charge of patient.
- Performing a Müller maneuver after the passive leg raising test. The Müller maneuver is used in current practice for measuring the maximum inspiratory pressue before performing an SBT. It consists of using a one-way valve connected to the intubation tube allowing forced inspiration with a closed glottis, and lasts about twenty seconds.
- Measurement of cardiac output before and after a passive leg raisong, a Müller maneuver and an SBT.
Since the observation of cardiac output during the Müller maneuver is not taken into account for the management of patients suitable for research, the research will not be able to lead to a direct benefit for the participants.
On the other hand, in the event of positive results of the study, a collective benefit is expected.
- Conditions
- Weaning, Spontaneous Breathing Trial
- Being tested
- Müller maneuver
- Keywords
- Weaning, Spontaneous breathing trial, Pulmonary edema, Passive leg raising, Cardiac output, Müller maneuver
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Müller maneuverOther
The Müller maneuver allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube and is currently used in routine care for diaphragmatic assessment. Ventilation through the one-way valve results in forced inspiration for about 20 seconds. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with preload reserve, i.e. in preload-dependent patients. The observation of an increase in cardiac output during a Müller maneuver could reflect the existence of a dependent preload state, i.e. with a reserve of preload, and de facto lower risk of pulmonary oedema. This test would be an easy alternative to the passive leg raising test used in current practice to evaluate the preload dependency and the risk of weaning induced pulmonary edema.
| Study group | Role | What they receive |
|---|---|---|
| Müller maneuver | Other | Open Label with intervention Müller maneuver Receives: Other: Müller maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pulmonary edema during an spontaneous breathing trial (SBT)
Occurrence of pulmonary edema during an SBT as defined by :
- A failure of the SBT defined by objective and subjective signs defined by Boles et al (signs of respiratory distress, agitation, cyanosis, tachycardia > 140 beats per minute, hypertension Pas > 180mmHg, respiratory rate > 35 cycles per minute) AND
- One or both of the following criteria :
- Ultrasound markers: E/e' ratio ≥ 13 + E/A ≥ 2
- Hemoconcentration markers (≥ 6% increase in plasma proteins or hemoglobin) The E/A and E/e' ratios are calculated automatically by the ultrasound machine.
The increase in proteins, and plasma hemoglobin are calculated according to the following formula:
Increase in plasma proteins and hemoglobin, (%) = ((final value - initial value) / initial value) x 100
Measured: During the spontaneous breathing trial (SBT)
Secondary outcomes (1)
Cardiac index before and after a passive leg raising test and a Müller maneuver
A positive spontaneous breathing trial (SBT) is defined by an increase of cardiac output > 10% ((value after-value before/value before))x100.
Measured: 1 minute before and during a passive leg raising test (when it induces its maximum effect, usually within a minute) and a Müller maneuver (when it induces its maximum effects, usually within 20 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start9 May 2022 (estimated)
- Primary completion9 May 2024 (estimated)
- Study completion9 Jul 2024 (estimated)
Why it stopped: This study received an unfavorable opinion from the Ethics Committee to extend the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic of weaning failure due to pulmonary edema
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra BEURTON, MD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358405
- Sponsor's protocol ID
- 2019-A02864-53
- Acronym
- PoEM
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Of Pulmonary Edema With Müller Maneuver
- ClinicalTrials.gov ID
- NCT05358405
- Acronym / sponsor ID
- PoEM / 2019-A02864-53
- Conditions
- Weaning, Spontaneous Breathing Trial
- Keywords
- Weaning, Spontaneous breathing trial, Pulmonary edema, Passive leg raising, Cardiac output, Müller maneuver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study received an unfavorable opinion from the Ethics Committee to extend the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 May 2022 (estimated)
- Primary completion
- 9 May 2024 (estimated)
- Study completion
- 9 Jul 2024 (estimated)
- First posted
- 3 May 2022 (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 mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient.
However, some patients fail this test and cannot be extubated. The main causes are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible. To assess the risk of pulmonary edema, cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, can be estimated using simple tests as the passive leg raising test before an SBT.
However, this test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care.
The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice.
The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation.
The study consist in the measurement of cardiac output before and after the passive leg raising test and the Müller maneuver, then measurement of cardiac output before and after an SBT.
A transthoracic ultrasound and a blood sample with dosage of proteins and hemoglobin will be carried out initially and then at the end of the SBT as part of routine care.
The investigators hypothesize:
- The Müller maneuver induces a greater increase in cardiac output in patients in a state of preload dependancy than in patients in a state of preload independancy.
- The absence of documented preload dependancy during a Müller maneuver is associated with the occurrence of pulmonary edema during an SBT.
The investigators included patients :
- > 18 years old, conscious patient, with health insurance, placed under mechanical ventilation for at least 24 hours ;
- In whom it was decided to perform a passive leg raising test and an SBT. The investigators excluded pregnancy, patient with chest tube, particpation in another interventional study, tracheostomy, patient under legal protection.
Detailed description
The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient. The main causes of weaning failure are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible.
To predict the risk of pulmonary edema, physician could 1/ estimate the cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, using simple tests as the passive leg raising test before an SBT. This test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care 2/ measure the hemoconcentration (hemoglobin and protein variation before and after SBT). However, this tests are not easy in intensive care unit.
The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice.
The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation. The investigators include patients:
- Placed under mechanical ventilation for at least 24 hours ;
- In whom it was decided to perform a leg lift test and an SBT. Patients are intubated and ventilated on the ventilators of the intensive care unit (v500, Dräger Medical, Lübeck, Germany or Carescape r860, GE Healthcare, Buc, France). The initial settings are decided by the physician in charge of the patient according to the gas exchanges.
The passive leg raising test consists of transferring a patient from a semi-sitting position to a position in which the trunk is horizontal and the lower limbs are elevated at 45°. This is achieved by the electrically operated bed. The test is considered positive (preload dependency) if the cardiac output increases more than 10%. This test is performed in common practice to assess the cardiac preload of patients before an SBT. The cardiac output is measured by transpulmonary thermodilution (if the patient is equiped by this dispositif before the study) or by cardiac echography.
SBT consists of reproducing the ventilation conditions once the patient has been extubated. This test is carried out using a so-called "T" piece connected to the end of the intubation tube or by canceling the assistance of the ventilator during 30 minutes. This test is performed daily in intensive care in the intubated patient before any extubation.The determination of hemoglobin and plasma proteins consists of a blood sample via a catheter already in place and its analysis before and after the SBT. An increase in hemoglobin or plasmatique proteins by 6% detect a weaning pulmonary edema .
The acts/procedures added by the search are:
- Transthoracic ultrasound added for research if the monitoring system PiCCO2 is not set up in the patient as part of the treatment. Transthoracic echocardiography is a medical imaging technique based on the use of ultrasound, inaudible, painless and harmless sound waves that allow visualization of the cardiac silhouette, its functioning and allows measurement of cardiac output, fraction ventricular ejection and other diagnostic parameters for left heart failure and pulmonary edema (E/A and E/e' ratios). This technique is used in routine daily practice by physicians in charge of patient.
- Performing a Müller maneuver after the passive leg raising test. The Müller maneuver is used in current practice for measuring the maximum inspiratory pressue before performing an SBT. It consists of using a one-way valve connected to the intubation tube allowing forced inspiration with a closed glottis, and lasts about twenty seconds.
- Measurement of cardiac output before and after a passive leg raisong, a Müller maneuver and an SBT.
Since the observation of cardiac output during the Müller maneuver is not taken into account for the management of patients suitable for research, the research will not be able to lead to a direct benefit for the participants.
On the other hand, in the event of positive results of the study, a collective benefit is expected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic of weaning failure due to pulmonary edema
| Arm | Type | Receives |
|---|---|---|
| Müller maneuver | Other | Other: Müller maneuverOpen Label with intervention Müller maneuver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18 years old ;
- With health insurance ;
- Placed under mechanical ventilation for at least 24 hours ;
- Conscious patient.
Key exclusion criteria (6 listed)
- Pregnancy (blood assay of βHCG) ;
- Participation in another intervention study ;
- Patient with chest tube
- Tracheostomy ;
- Patient under legal protection ;
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 |
|---|---|---|
| Müller maneuverThe Müller maneuver allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube and is currently used in routine care for diaphragmatic assessment. Ventilation through the one-way valve results in forced inspiration for about 20 seconds. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with preload reserve, i.e. in preload-dependent patients. The observation of an increase in cardiac output during a Müller maneuver could reflect the existence of a dependent preload state, i.e. with a reserve of preload, and de facto lower risk of pulmonary oedema. This test would be an easy alternative to the passive leg raising test used in current practice to evaluate the preload dependency and the risk of weaning induced pulmonary edema. | Other | Müller maneuver |
Primary outcome
Number of pulmonary edema during an spontaneous breathing trial (SBT)
Time frame: During the spontaneous breathing trial (SBT)
Occurrence of pulmonary edema during an SBT as defined by : * A failure of the SBT defined by objective and subjective signs defined by Boles et al (signs of respiratory distress, agitation, cyanosis, tachycardia > 140 beats per minute, hypertension Pas > 180mmHg, respiratory rate > 35 cycles per minute) AND * One or both of the following criteria : * Ultrasound markers: E/e' ratio ≥ 13 + E/A ≥ 2 * Hemoconcentration markers (≥ 6% increase in plasma proteins or hemoglobin) The E/A and E/e' ratios are calculated automatically by the ultrasound machine. The increase in proteins, and plasma hemoglobin are calculated according to the following formula: Increase in plasma proteins and hemoglobin, (%) = ((final value - initial value) / initial value) x 100
1 secondary outcome
Cardiac index before and after a passive leg raising test and a Müller maneuver
Time frame: 1 minute before and during a passive leg raising test (when it induces its maximum effect, usually within a minute) and a Müller maneuver (when it induces its maximum effects, usually within 20 seconds)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Alexandra BEURTON, MD principal investigator
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Müller maneuver in people with Weaning and Spontaneous Breathing Trial, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 11 Feb 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of pulmonary edema during an spontaneous breathing trial (SBT) (time frame: During the spontaneous breathing trial (SBT)). 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 11 Feb 2026.