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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Measure lung and chest wall elastance with esophageal catheter
non-invasive method for measuring the lung elastance
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome (ARDS), positive end expiratory pressure (PEEP), Staircase recruitment maneuver (SRM), Lung elastance, chest wall elastance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur mer

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Unique arm

Arm Description

Experimental and comparator

Outcomes

Primary Outcome Measures

lung and chest wall elastance
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

Direct volume measurements
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
To set positive end expiratory pressure (PEEP)
The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),
To Set positive end expiratory pressure (PEEP)
The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)
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).
to set positive end expiratory pressure (PEEP)

Full Information

First Posted
July 11, 2013
Last Updated
May 11, 2017
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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1. Study Identification

Unique Protocol Identification Number
NCT01899560
Brief Title
ELASTANCE: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated ARDS Patients
Acronym
ELASTANCE
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 27, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute respiratory distress syndrome (ARDS), positive end expiratory pressure (PEEP), Staircase recruitment maneuver (SRM), Lung elastance, chest wall elastance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unique arm
Arm Type
Other
Arm Description
Experimental and comparator
Intervention Type
Procedure
Intervention Name(s)
Measure lung and chest wall elastance with esophageal catheter
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
non-invasive method for measuring the lung elastance
Intervention Description
by measuring volume recruited during a change of pressure (∆PEEP/∆EELV)
Primary Outcome Measure Information:
Title
lung and chest wall elastance
Description
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.
Time Frame
1 Hour
Secondary Outcome Measure Information:
Title
Direct volume measurements
Description
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
Time Frame
1 Hour
Title
the pressure associated with the largest hysteresis on the PV curve
Description
To set positive end expiratory pressure (PEEP)
Time Frame
1 hour
Title
The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),
Description
To Set positive end expiratory pressure (PEEP)
Time Frame
1 hour
Title
The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)
Description
To set positive end expiratory pressure (PEEP)
Time Frame
1 Hour
Title
- 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).
Description
to set positive end expiratory pressure (PEEP)
Time Frame
1 Hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Toulon La Seyne sur mer
City
Toulon
State/Province
Paca
ZIP/Postal Code
83056
Country
France

12. IPD Sharing Statement

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

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