Effects of the Open Lung Concept following ARDSnet Ventilation in Patients with Early ARDS

Not Applicable

• Conditions: C08.381.840; Adult Respiratory Distress Syndrome

• Registration Number: RBR-5zm9pr
• Lead Sponsor: niversidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with the diagnosis of Distress Respiratory Syndrome presenting PaO2/FIO2 lower than 300 mmHg after 30 min of mechanical ventilation with a PEEP of 5 cmH2O and an FIO2 of 1.0 and a VT ranging from 8 to 10 mL/kg of ideal body weight along with hemodynamically stable parameters (mean arterial pressures higher than 65 mmHg and arterial lactates lower than 3 mg/dL) over the preceding 6 hours.

Exclusion Criteria

Patients with the diagnosis of Adult Distress Syndrome for more than 48 h. Diagnosis of pneumothorax. Diagnosis of pneumomediastinum. Bronchopleural fistula. Subpleural blebs. Increased intracranial pressure. Body weight greater than 140 kg. Pregnancy. Coexistent disease with an expected 6-month mortality risk exceeding 50%.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected endpoint - Improvement of pulmonar aeration when ventilation with the concept of open lung was applied, in comparison with ventilation according ARDSnet protocol<br><br>Observed endpoint - A higher fraction of normally aerated regions(P=0.015), with a lower fraction of collapsed regions (P=0.018), were observed with the Open Lung Concept when compared with ARDSnet protocol. No significant differences in hyperinflated regions were observed (P=0.179) among groups. ;Expected endpoint - Improvement of respiratory function (PaO2/FIO2)when ventilation with the concept of open lung was applied, in comparison with ventilation according ARDSnet protocol<br><br>Observed endpoint - Significant improvement of respiratory function with ventilation according to open lung concept in comparison with ventilation according ARDSnet protocol(median of PaO2/FIO2=270 mmHg vs 177 mmHg, respectively).

Secondary Outcome Measures

Name	Time	Method
Expected endpoint - Stable serum levels of inflamatory markers when ventilation with the concept of open lung was applied, in comparison with ventilation according ARDSnet protocol<br><br>Observed endpoint - Stable inflammatory markers with ventilation according to open lung concept were observed.