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

Evaluation of a Sequential Ventilatory Strategy in Patients with Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5zm9pr
Enrollment
Unknown
Registered
2015-11-04
Start date
2010-01-04
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Adult Respiratory Distress Syndrome

Interventions

Fifteen patients were initially ventilated according to the ARDSnet protocol. During the next 24h,patients were divided in 2 groups. Group 1 with nine patients who were ventilated according to the Ope
Other

Sponsors

Universidade de São Paulo
Lead Sponsor
Hospital Copa Dor
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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%.

Design outcomes

Primary

MeasureTime frame
Expected endpoint - Improvement of pulmonar aeration when ventilation with the concept of open lung was applied, in comparison with ventilation according ARDSnet protocol 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 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

MeasureTime frame
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 Observed endpoint - Stable inflammatory markers with ventilation according to open lung concept were observed.

Countries

Brazil

Contacts

Public ContactVivian Rotman

Universidade Federal do Rio de Janeiro

vrotman@gmail.com5521988224889

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 12, 2026