High Tidal Volume Induces Inflammation In Normal Lungs

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.

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Key information

Conditions

Mechanically Ventilated Patients Normal Lungs

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complexo Hospitalar Santa Casa, Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low tidal volume

Procedure

twenty patients were randomly (opaque sealed envelopes) assigned to receive mechanical ventilation in volume-controlled mode either with VT of 10-12 ml/kg predicted body weight (high VT group, n=10) or with VT of 5-7 ml/kg predicted body weight (low VT group, n=10) with an inspiratory fraction of oxygen (FIO2) set at the minimal level at which an arterial oxygen saturation of > 90% and minimal PEEP (4-5cmH2O). The predicted body weight of male patients was calculated as equal to 50+0.91(centimeters of height-152.4); that of female patients was calculated as equal to 45.5+0.91(centimeters of height-152.4).

Low Tidal Volume

Other

tidal volume of 5-7 ml/kg predicted body weight

Primary outcomes

Lung cytokines in mechanically ventilated patients

Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

Faculdade de Medicina
Programa de Pós-Graduação em Clínica Médica

Registry information

Official study title

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

Acronym: Normallung

Important dates

First posted: Jul 9, 2009
Registry last updated: Jul 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed