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High Tidal Volume Induces Inflammation In Normal Lungs (Normallung)

Primary Purpose

Mechanically Ventilated Patients, Normal Lungs

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low tidal volume
Low tidal volume
low tidal volume
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mechanically Ventilated Patients focused on measuring Ventilator-associated lung injury, Tumor necrosis factor-alpha, Interleukin-8, Mechanical ventilation, Low tidal volume ventilation, Normal lungs

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Complexo Hospitalar Santa Casa
  • Hospital de Pronto Socorro

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

high VT group

Low tidal volume

Arm Description

Outcomes

Primary Outcome Measures

Lung cytokines in mechanically ventilated patients

Secondary Outcome Measures

Full Information

First Posted
July 8, 2009
Last Updated
July 8, 2009
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Programa de Pós-Graduação em Clínica Médica, Faculdade de Medicina
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1. Study Identification

Unique Protocol Identification Number
NCT00935896
Brief Title
High Tidal Volume Induces Inflammation In Normal Lungs
Acronym
Normallung
Official Title
Mechanical Ventilation With High Tidal Volume Induces Inflammation In Patients Without Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Programa de Pós-Graduação em Clínica Médica, Faculdade de Medicina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanically Ventilated Patients, Normal Lungs
Keywords
Ventilator-associated lung injury, Tumor necrosis factor-alpha, Interleukin-8, Mechanical ventilation, Low tidal volume ventilation, Normal lungs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high VT group
Arm Type
No Intervention
Arm Title
Low tidal volume
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Low tidal volume
Intervention Description
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
Intervention Name(s)
Low tidal volume
Intervention Description
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
Other
Intervention Name(s)
low tidal volume
Intervention Description
tidal volume of 5-7 ml/kg predicted body weight
Primary Outcome Measure Information:
Title
Lung cytokines in mechanically ventilated patients
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 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.
Facility Information:
Facility Name
Complexo Hospitalar Santa Casa
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
900000
Country
Brazil
Facility Name
Hospital de Pronto Socorro
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90000
Country
Brazil

12. IPD Sharing Statement

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