High Tidal Volume Induces Inflammation In Normal Lungs

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935896

Acronym

Normallung

Enrollment

Registered

2009-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2009-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDURELow 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).

OTHERlow tidal volume

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

Study design

Allocation

RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Lung cytokines in mechanically ventilated patients	30 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026