Prediction Of Pulmonary Edema With Müller Maneuver
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of pulmonary edema during an spontaneous breathing trial (SBT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Experimental
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years old ;
- •With health insurance ;
- •Placed under mechanical ventilation for at least 24 hours ;
- •Conscious patient.
排除标准
- •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).
研究组 & 干预措施
Müller maneuver
Open Label with intervention Müller maneuver
干预措施: Müller maneuver (Other)
结局指标
主要结局
Number of pulmonary edema during an spontaneous breathing trial (SBT)
时间窗: 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
次要结局
- 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))