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Randomized, pilot, multicenter clinical study in Brazil to assess the feasibility of Improvement of static lung compliance by different Positive End Expiratory Pulmonary Pressure titration methods in patients with Adult Respiratory Distress Syndrome

Randomized, pilot, multicenter clinical study in Brazil to assess the feasibility of improvement of static lung compliance by different PEEP Titration Methods in patients with ARDS - PEEP ARDS Positive End Expiratory Pressure Adult Respiratory Distress Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9b7jbxm
Enrollment
Unknown
Registered
2022-12-30
Start date
2018-02-28
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

Respiratory Distress Syndrome

Interventions

There will be 4 groups for Positive End Expiratory Pressure (PEEP) titration, 3 for intervention and 1 control group. The first group or Control group PEEP titration will be done according to PEEP tab
E02.041.625.790
G01.374.590.210
E07.305.812.901
E01.370.350.825

Sponsors

Hospital Nereu Ramos
Lead Sponsor
Hospital Nereu Ramos
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Intubated patients of both gender with mechanical ventilation; ARDS Berlin Criteria with less than 72 hours; older than 18 years old

Exclusion criteria

Exclusion criteria: High dose of vasoactive drugs; Intracranial hypertension; Patients with acute myocardial infarction; Presence of pneumothorax, subcutaneous emphysema, pneumomediastinum, or pneumatocele; Paliative care exclusive patients; Severe thoracic trauma and/or thorax drainage; Patients with pacemaker or automatic desfibrilators

Design outcomes

Primary

MeasureTime frame
Comparison between the difference in compliance between days 1 and 3 between the four titration methods expressed in ml/cmH2O. The compliance is measured at day 1, 2 and 3. It is calculated with ventilatory parameters shown at the ventilator: tidal volume divided by plateau minus peep.—

Secondary

MeasureTime frame
Difference in PaO2 between groups measured as the difference in paO2 given in mmHg between 4 groups of randomization ;Correlation between airway driving pressure and trans pulmonary driving pressure expressed as percentage of transpulmonary driving pressure divided by airway driving pressure. ;Presence of barotrauma measured as binary variable: yes or no e measured with the number of events devided by total of patients;Presence of severe respiratory acidosis (ph<7,15) measured as a binary variable: yes or no. Dividing number of events divided by total. ;28 day mortality measured as percentage of total death divided by number of patients at total. ;Number of mechanical ventilation free days in 28 days measured as the number of days out of mechanical ventilation in 28 days considering zero for those who died in 28 days;Comparison of dead space (Vd)/tidal volume (Vt) between groups measure as a ratio.—

Countries

Brazil

Contacts

Public ContactIsrael Maia

Hospital Nereu Ramos

israels.maia@gmail.com+55 48 984131510

Outcome results

None listed

Source: REBEC (via WHO ICTRP)