Mechanical Ventilation With High Tidal Volume Induces Inflammation In Patients Without Lung Disease

Federal University of Rio Grande do Sul2 sites in 1 country20 target enrollmentJuly 9, 2009

ConditionsMechanically Ventilated Patients Normal Lungs

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mechanically Ventilated Patients
Sponsor: Federal University of Rio Grande do Sul
Enrollment: 20
Locations: 2
Primary Endpoint: Lung cytokines in mechanically ventilated patients
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Objective: To compare the effects of a protective versus a conventional ventilatory strategy, on systemic and in lung production of tumor necrosis factor-alpha (TNF-alpha) and interleukin-8 (IL-8) in patients without lung disease.

Hypothesis: High tidal volumes induce inflammation in patients without lung disease Design: Prospective control-randomized study. Patients and Setting: Twenty patients without lung disease and submitted to mechanical ventilation admitted to one trauma and one general adult intensive care unit of two different university hospitals.

Interventions: Patients were randomized to receive mechanical ventilation either with tidal volume (VT) of 10-12 ml/kg predicted body weight (high VT group) or with VT of 5-7 ml/kg predicted body weight (low VT group) with an O2 inspiratory fraction (FIO2) enough to keep arterial oxygen saturation > 90% with positive end-expiratory pressure (PEEP) of 5 cmH2O during 12 hours after admission to the study.

Registry

clinicaltrials.gov

Start Date

July 9, 2009

End Date

TBD

Last Updated

16 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Federal University of Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

•age ≥ 16 years;
•anticipated survival \> 24 hours;
•need for mechanical ventilation for at least 12 hours and
•hemodynamic stability (MAP\>65 mmHg, HR\<100 beats/min, diuresis \> 1 ml/kg/h, no catecholamine requirement or fluid challenge).

Exclusion Criteria

•history of any lung disease, use of immunosuppressive medication, recent infections, previous thromboembolic disease, recent ventilatory support, and participation in another clinical trial. Absence of lung disease was defined by the following clinical criteria: (a) no evidence of respiratory infection (white blood cell count \<10x103/µl, temperature \> 380C, purulent sputum), (b) normal chest roentgenogram, (c) PaO2/FIO2 ratio \> 300, (d) and a normal clinical respiratory history.