High Tidal Volume Induces Inflammation In Normal Lungs

NCT ID: NCT00935896

Last Updated: 2009-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

high VT group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low tidal volume

Group Type: EXPERIMENTAL

Low tidal volume

Intervention Type: 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

Intervention Type: PROCEDURE

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)

low tidal volume

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: 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)

Intervention Type: PROCEDURE

low tidal volume

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Programa de Pós-Graduação em Clínica Médica

UNKNOWN

Sponsor Role: collaborator

Faculdade de Medicina

AMBIG

Sponsor Role: collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Faculdade de Medicina - Universidade Federal do Rio Grande do Sul

Locations

Complexo Hospitalar Santa Casa

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Pronto Socorro

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

CAPES-PROF - UFRGS

Identifier Type: -

Identifier Source: secondary_id

normal lung - V1

Identifier Type: -

Identifier Source: org_study_id