N/A
N=320
Intensive Alveolar Recruitment Protocol After Cardiac Surgery
Ventilator Induced Lung Injury · Cardiac Disease · Acute Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT01502332 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Severity of Pulmonary Complications in the Post-operative Period — 15; 26 percentage of participants — p=0.016
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensive Alveolar Recruitment (Other); Moderate Alveolar Recruitment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Pulmonary Complications in the Post-operative Period |
15; 26 | 0.016 sig |
| SECONDARY Length of ICU Stay |
3; 3 | 0.014 sig |
| SECONDARY Length of Hospital Stay |
8; 9 | 0.037 sig |
| SECONDARY Incidence of Barotrauma |
0; 1 | — |
| SECONDARY Hospital Mortality |
3; 5 | 0.267 |
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.
Eligibility Criteria
Inclusion Criteria
- Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
- Age > 18 years and 35%
- Body mass index 2 micrograms/Kg/min
- Acute arrhythmias
- Blooding associated to hemodynamic instability
- Need of re-surgery and/or mechanical circulatory assistance
- Suspicion of neurological alteration
- Chest tube with persistent air leak
Data sourced from ClinicalTrials.gov (NCT01502332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.