High Tidal Volume Induces Inflammation In Normal Lungs

NCT00935896 | Completed

• 2 other identifiers: normal lung - V1CAPES-PROF - UFRGS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Mechanically Ventilated Patients; Normal Lungs

Keywords

Ventilator-associated lung injury; Tumor necrosis factor-alpha; Interleukin-8; Mechanical ventilation; Low tidal volume ventilation; Normal lungs

Outcome Measures

Primary Outcomes (1)

• Lung cytokines in mechanically ventilated patients

  30 months

Study Arms (2)

high VT group

NO INTERVENTION

Low tidal volume

EXPERIMENTAL

Procedure: Low tidal volume; Other: low tidal volume

Interventions

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Programa de Pós-Graduação em Clínica Médica: collaborator
• Faculdade de Medicina: collaborator

Study Sites (2)

Complexo Hospitalar Santa Casa

Porto Alegre, Rio Grande do Sul, 900000, Brazil

Location

Hospital de Pronto Socorro

Porto Alegre, Rio Grande do Sul, 90000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Last Updated: July 9, 2009

Record last verified: 2009-07

Locations

BR (2)