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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01899560
Acronym
ELASTANCE
Enrollment
12
Registered
2013-07-15
Start date
2013-03-31
Completion date
2014-11-27
Last updated
2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREMeasure lung and chest wall elastance with esophageal catheter

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.

OTHERnon-invasive method for measuring the lung elastance

by measuring volume recruited during a change of pressure (∆PEEP/∆EELV)

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
lung and chest wall elastance1 HourMeasure 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

MeasureTime frameDescription
Direct volume measurements1 HourDetermine 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 curve1 hourTo set positive end expiratory pressure (PEEP)
The deflection point on the low flow PV curve (ref Hickling AJRCCM 2001),1 hourTo Set positive end expiratory pressure (PEEP)
The minimal PEEP to obtain an positive end-expiratory transpulmonary pressure (ref Talmor NEJM 2009)1 HourTo 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 Hourto set positive end expiratory pressure (PEEP)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026