ELASTANCE: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated ARDS Patients

Phase 3

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Procedure: Measure lung and chest wall elastance with esophageal catheter; Other: non-invasive method for measuring the lung elastance

• Registration Number: NCT01899560
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-06
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Study Completion: 2014-11-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unique arm	non-invasive method for measuring the lung elastance	Experimental and comparator
Unique arm	Measure lung and chest wall elastance with esophageal catheter	Experimental and comparator

Primary Outcome Measures

Name	Time	Method
lung and chest wall elastance	1 Hour	Measure lung and chest wall elastance with esophageal catheter and compare with the non-invasive method at each level of positive end expiratory pressure (PEEP) during recruitment from 5 to 40 cmH2O and derecruitment from 40 to 5 cmH2O.

Secondary Outcome Measures

Name	Time	Method
Direct volume measurements	1 Hour	Determine dynamics of recruitment and derecruitement by direct volume measurements in early onset mechanically ventilated ARDS patients to determine optimal duration and number of breath required for each step during a SRM and a decreasing PEEP trial
the pressure associated with the largest hysteresis on the PV curve	1 hour	To set positive end expiratory pressure (PEEP)
The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),	1 hour	To Set positive end expiratory pressure (PEEP)
The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)	1 Hour	To set positive end expiratory pressure (PEEP)
- 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).	1 Hour	to set positive end expiratory pressure (PEEP)

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Toulon La Seyne sur mer; 🇫🇷 Toulon, Paca, France