High Tidal Volume Induces Inflammation In Normal Lungs

Not Applicable

Completed

• Conditions: Mechanically Ventilated Patients; Normal Lungs
• Interventions: Other: low tidal volume

• Registration Number: NCT00935896
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Last Update Submitted: 2009-07-08
• Study First Posted: 2009-07-09
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low tidal volume	low tidal volume	-

Primary Outcome Measures

Name	Time	Method
Lung cytokines in mechanically ventilated patients	30 months

Trial Locations

Locations (2)

Complexo Hospitalar Santa Casa; 🇧🇷 Porto Alegre, RS, Brazil

Hospital de Pronto Socorro; 🇧🇷 Porto Alegre, RS, Brazil