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

NCT ID: NCT01899560

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-11-27

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Unique arm

Experimental and comparator

Group Type: OTHER

Measure lung and chest wall elastance with esophageal catheter

Intervention Type: PROCEDURE

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.

non-invasive method for measuring the lung elastance

Intervention Type: OTHER

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

Interventions

Measure 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.

Intervention Type: PROCEDURE

non-invasive method for measuring the lung elastance

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Intercommunal de Toulon La Seyne sur mer

Toulon, Paca, France

Countries

France

Other Identifiers

CH-2012-03 2012-A01160-43

Identifier Type: -

Identifier Source: org_study_id