High Tidal Volume Induces Inflammation In Normal Lungs (Normallung)

Federal University of Rio Grande do Sul

Status: Completed

Conditions: Mechanically Ventilated Patients; Normal Lungs

Treatments: Other: low tidal volume; Procedure: Low tidal volume

Study type: Interventional

Funder types: Other

Identifiers

NCT00935896

normal lung - V1

CAPES-PROF - UFRGS

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

high VT group

No Intervention group

Low tidal volume

Experimental group

Treatment:

Procedure: Low tidal volume

Other: low tidal volume

Procedure: Low tidal volume