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Clinical Trials/NCT01899560
NCT01899560
Completed
Phase 3

Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated Acute Respiratory Distress Syndrome (ARDS)Patients

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer1 site in 1 country12 target enrollmentMarch 2013

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Enrollment
12
Locations
1
Primary Endpoint
lung and chest wall elastance
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
November 27, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

lung and chest wall elastance

Time Frame: 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 Outcomes

  • Direct volume measurements(1 Hour)
  • the pressure associated with the largest hysteresis on the PV curve(1 hour)
  • The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),(1 hour)
  • The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)(1 Hour)
  • - 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)

Study Sites (1)

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