CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 320 enrolled
Drug / intervention
Intensive Alveolar Recruitment +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01502332
NCT01502332N/ACompleted

Comparison of Two Protective Mechanical Ventilation Strategies After Cardiac Surgery: Aggressive Versus Moderate Alveolar Recruitment Strategies

University of Sao Paulo·interventional·Posted Dec 30, 2011·Updated Nov 23, 2016

In Brief

A clinical study evaluating Intensive Alveolar Recruitment and Moderate Alveolar Recruitment for Ventilator Induced Lung Injury and 2 related conditions. Completed, enrolled 320 participants across 1 site.

Detailed Summary

The purpose of this study was to evaluate prospectively the impact of two protective mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw) after cardiac surgery. The study selected patients presenting signals of deficient gas exchange (PaO2/FIO2 \< 250 at a PEEP \[positive end expiratory pressure\] of 5 cmH2O) in the immediate post-operative period. An aggressive alveolar recruitment protocol applying opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the standard alveolar recruitment protocol of the institution, where an opening pressure of 20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing period of four hours of controlled mechanical ventilation, the patients followed the routine weaning protocol and physiotherapy protocol of the institution.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2011
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.5 years ago

Interventions

Intensive Alveolar Recruitmentother

Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with tidal volume (VT) = 6 mL/kg/pbw.

Moderate Alveolar Recruitmentother

Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.