- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01899560
ELASTANCE: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated ARDS Patients (ELASTANCE)
Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated Acute Respiratory Distress Syndrome (ARDS)Patients
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Paca
-
Toulon, Paca, France, 83056
- Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Unique arm
Experimental and comparator
|
Patients will be in supine position with 30-45° head of bed elevation. The cuff of the endotracheal tube will be transiently overinflated to 60 cmH2O to ensure there will be no air leaks. NMBA (cisatracurium) will be administrated [9]. The fraction of inspired oxygen (FiO2) will be adjusted for continuously monitored oxygen saturation (SpO2) between 90 to 94%. Patients will be ventilated in pressure control with 15 cmH2O of driving pressure. A low flow pressure/volume curve from 0 to 40 cmH2O will be performed.
by measuring volume recruited during a change of pressure (∆PEEP/∆EELV)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direct volume measurements
Time Frame: 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
|
1 Hour
|
the pressure associated with the largest hysteresis on the PV curve
Time Frame: 1 hour
|
To set positive end expiratory pressure (PEEP)
|
1 hour
|
The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),
Time Frame: 1 hour
|
To Set positive end expiratory pressure (PEEP)
|
1 hour
|
The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)
Time Frame: 1 Hour
|
To set positive end expiratory pressure (PEEP)
|
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).
Time Frame: 1 Hour
|
to set positive end expiratory pressure (PEEP)
|
1 Hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH-2012-03 2012-A01160-43
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