Clinical trial NCT01899560: ELASTANCE: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated ARDS Patients
Official title: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated Acute Respiratory Distress Syndrome (ARDS)Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome (ARDS)
positive end expiratory pressure (PEEP)
Staircase recruitment maneuver (SRM)
Lung elastance
chest wall elastance
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The recruitment strategy in Acute respiratory distress syndrome (ARDS) patients mechanically ventilated combines recruitment maneuvers and positive end expiratory pressure (PEEP). Recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung volume in order to prevent repetitive opening and closing of unstable lung units and reduce the strain induced by ventilation. In addition, recruitment is effective in improving oxygenation. Variety of recruitment maneuver have been described, the most commonly used is the application of sustained continuous positive airway pressure at 40 cmH2O for 40 seconds. Staircase recruitment maneuver (SRM) is an alternative with good hemodynamic tolerance. Staircase recruitment maneuver (SRM) involves a progressive increase in positive end expiratory pressure (PEEP) (up to 40 cmH2O), in pressure control ventilation, in order to increase end-expiratory lung volume (EELV); then a decreasing PEEP trial is performed. The positive end expiratory pressure (PEEP) to prevent alveolar collapse depends on ratio between lung elastance and chest wall elastance. If chest wall elastance is high, the PEEP to obtain a positive end-expiratory transpulmonary pressure is high. The only way for the time being to know the transpulmonary pressure and the ratio between lung and chest wall elastance is the use of esophageal catheter. A non-invasive method for measuring the lung elastance by measuring volume recruited during a change of pressure (∆PEEP/∆EELV) could be used to avoid the use of esophageal catheter.


Eligibility criteria: Inclusion Criteria:

Early onset (less than 24 hours)moderate or severe Acute respiratory distress syndrome (ARDS) according to Berlin Definition

Mechanical ventilation for less than 72 hours

Exclusion Criteria:

Bronchopleural fistula, Emphysema, Pneumothorax, Antecedent of pneumothorax, Increase intracranial pressure, Pulmonary arterial hypertension with right heart failure, Hemodynamic instability with mean arterial pressure \< 65 mmHg, Pregnancy.

Primary outcomes:
measure: lung and chest wall elastance
timeFrame: 1 Hour
Secondary outcomes:
measure: Direct volume measurements
timeFrame: 1 Hour
measure: the pressure associated with the largest hysteresis on the PV curve
timeFrame: 1 hour
measure: The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),
timeFrame: 1 hour
measure: The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)
timeFrame: 1 Hour
measure: - the derecruitment point by SpO2 monitoring during the decreasing positive end expiratory pressure (PEEP)trial (The derecruitment point will be defined as positive end expiratory pressure (PEEP) for which SpO2 decrease) (ref Girgis RC2006).
timeFrame: 1 Hour
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
state: Paca
Study officials:
References: