High Tidal Volume Induces Inflammation In Normal Lungs (Normallung)

This study has been completed.
Sponsor:
Collaborators:
Programa de Pós-Graduação em Clínica Médica
Faculdade de Medicina
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00935896
First received: July 8, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 8, 2009
July 8, 2009
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Lung cytokines in mechanically ventilated patients [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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High Tidal Volume Induces Inflammation In Normal Lungs
Mechanical Ventilation With High Tidal Volume Induces Inflammation In Patients Without Lung Disease

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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Interventional
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Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
  • Mechanically Ventilated Patients
  • Normal Lungs
  • Procedure: Low tidal volume
    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).
  • Procedure: Low tidal volume
    Immediately after ICU admission, once all inclusion and exclusion criteria were met and consent obtained, twenty patients (16 men, 4 women, median age of 49 yrs) 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)
  • Other: low tidal volume
    tidal volume of 5-7 ml/kg predicted body weight
  • No Intervention: high VT group
  • Experimental: Low tidal volume
    Interventions:
    • Procedure: Low tidal volume
    • Procedure: Low tidal volume
    • Other: low tidal volume
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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.

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00935896
normal lung - V1, CAPES-PROF - UFRGS
No
Prof. Gilberto Friedman, Faculdade de Medicina - Universidade Federal do Rio Grande do Sul
Federal University of Rio Grande do Sul
  • Programa de Pós-Graduação em Clínica Médica
  • Faculdade de Medicina
Not Provided
Federal University of Rio Grande do Sul
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP