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
  Purpose

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.


Condition Intervention
Mechanically Ventilated Patients
Normal Lungs
Procedure: Low tidal volume
Other: low tidal volume

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mechanical Ventilation With High Tidal Volume Induces Inflammation In Patients Without Lung Disease

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Lung cytokines in mechanically ventilated patients [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Arms Assigned Interventions
No Intervention: high VT group
Experimental: Low tidal volume 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00935896

Locations
Brazil
Complexo Hospitalar Santa Casa
Porto Alegre, RS, Brazil, 900000
Hospital de Pronto Socorro
Porto Alegre, RS, Brazil, 90000
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Programa de Pós-Graduação em Clínica Médica
Faculdade de Medicina
  More Information

No publications provided

Responsible Party: Prof. Gilberto Friedman, Faculdade de Medicina - Universidade Federal do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT00935896     History of Changes
Other Study ID Numbers: normal lung - V1, CAPES-PROF - UFRGS
Study First Received: July 8, 2009
Last Updated: July 8, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
Ventilator-associated lung injury
Tumor necrosis factor-alpha
Interleukin-8
Mechanical ventilation
Low tidal volume ventilation
Normal lungs

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014