Mechanically Ventilated PatientsNormallungNCT00935896
High Tidal Volume Induces Inflammation In Normal Lungs
A study testing Low tidal volume in people with Mechanically Ventilated Patients and Normal Lungs, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mechanically Ventilated Patients, Normal Lungs
- What is being tested?
- Low tidal volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Complexo Hospitalar Santa Casa
Porto Alegre, Rio Grande do Sul, 900000
Hospital de Pronto Socorro
Porto Alegre, Rio Grande do Sul, 90000
About this study
Official title: Mechanical Ventilation With High Tidal Volume Induces Inflammation In Patients Without Lung Disease
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
- Being tested
- Low tidal volume
- Keywords
- Ventilator-associated lung injury, Tumor necrosis factor-alpha, Interleukin-8, Mechanical ventilation, Low tidal volume ventilation, Normal lungs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low tidal volumeProcedure or surgery
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 volumeProcedure or surgery
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 volumeOther
tidal volume of 5-7 ml/kg predicted body weight
| Study group | Role | What they receive |
|---|---|---|
| high VT group | No intervention | Not described |
| Low tidal volume | Experimental | Not described Receives: Procedure: Low tidal volume; Other: low tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cytokines in mechanically ventilated patients
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Programa de Pós-Graduação em Clínica Médica, Faculdade de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935896
- Sponsor's protocol ID
- normal lung - V1
- Other IDs
- CAPES-PROF - UFRGS
- Acronym
- Normallung
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation With High Tidal Volume Induces Inflammation In Patients Without Lung Disease
- ClinicalTrials.gov ID
- NCT00935896
- Acronym / sponsor ID
- Normallung / normal lung - V1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Programa de Pós-Graduação em Clínica Médica, Faculdade de Medicina
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high VT group | No intervention | – |
| Low tidal volume | Experimental | Procedure: Low tidal volume, Other: low tidal volume |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low tidal volumetwenty 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 or surgery | Low tidal volume |
| Low tidal volumeImmediately 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) | Procedure or surgery | Low tidal volume |
| low tidal volumetidal volume of 5-7 ml/kg predicted body weight | Other | Low tidal volume |
Primary outcome
Lung cytokines in mechanically ventilated patients
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low tidal volume in people with Mechanically Ventilated Patients and Normal Lungs, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cytokines in mechanically ventilated patients (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2009.