Prediction Of Pulmonary Edema With Müller Maneuver

NCT05358405 | Withdrawn

• 1 other identifier: 2019-A02864-53
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Weaning; Spontaneous Breathing Trial

Keywords

Weaning; Spontaneous breathing trial; Pulmonary edema; Passive leg raising; Cardiac output; Müller maneuver

Outcome Measures

Primary Outcomes (1)

• 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

  During the spontaneous breathing trial (SBT)

Secondary Outcomes (1)

• Cardiac index before and after a passive leg raising test and a Müller maneuver

  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)

Study Arms (1)

Müller maneuver

OTHER

Open Label with intervention Müller maneuver

Other: Müller maneuver

Interventions

Müller maneuver OTHER

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.

Müller maneuver

Eligibility Criteria

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

You may qualify if:

• Men and women over 18 years old ;
• With health insurance ;
• Placed under mechanical ventilation for at least 24 hours ;
• Conscious patient.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexandra BEURTON, MD

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Experimental
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic of weaning failure due to pulmonary edema

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: May 3, 2022
• Study Start: May 9, 2022
• Primary Completion: May 9, 2024
• Study Completion: July 9, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)