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Ventilation with Lower Tidal Volumes as Compared to Traditional Tidal Volumes of Patients not Suffering from Acute Lung Injury.


- candidate number1254
- NTR NumberNTR151
- ISRCTNISRCTN82533884
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR27-aug-2005
- Secondary IDsN/A 
- Public TitleVentilation with Lower Tidal Volumes as Compared to Traditional Tidal Volumes of Patients not Suffering from Acute Lung Injury.
- Scientific TitleVentilation with Lower Tidal Volumes as Compared to Traditional Tidal Volumes of Patients not Suffering from Acute Lung Injury.
- ACRONYMHiLoNali
- hypothesisWe hypothesize that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.
- Healt Condition(s) or Problem(s) studiedMechanical ventilation, complications
- Inclusion criteriaPatients who are intubated and expected to receive mechanical ventilation for > 72 hours are eligible for the study if they do not suffer from ALI/ARDS, according to the American/European consensus criteria.
- Exclusion criteria1. > 36 hours after start of MV;
2. Are under 18;
3. Participation in other trials;
4. Pregnancy;
5. Increased uncontrolable intracranial pressure;
6. Severe chronic respiratory disease (daily medication);
7. Pneumonia;
8. Use of corticosteroids (systemic or local) or other immunosuppressive agents;
9. Pulmonary thrombo-embolism;
10. After pneumonectomy or lobectomy;
11. Previous randomisation in this study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate1-jan-2007
- Target number of participants200
- InterventionsPatients are randomly assigned to receive mechanical ventilation involving either traditional VT (10 ml/kg PBW) or lower VT (6 ml/kg PBW).
All patients will undergo a minilavage every second day, preceded by blood sampling.
- Primary outcome1. Local inflammatory responses;
2. Local Fibrin turnover;
3. Systemic levels of biomarkers of lung injury.
- Secondary outcomeLate ALI/ARDS.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schultz
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
[default]
- Publications
- Brief summaryMechanical ventilation with lower tidal volumes (6 ml/kg predicted body weight [PBW]) reduces mortality and increases the number of days without ventilator use, as compared with traditional VT (12 ml/kg PBW).
It is uncertain whether this lung-protective approach should be advocated as a standard of care in non-ALI/ARDS patients as well. We hypothesize that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation. In this trial, patients not suffering from ALI/ARDS are randomly assigned to a mechanical ventilation strategy using either lower tidal volumes or traditional tidal volumes.
- Main changes (audit trail)
- RECORD20-aug-2005 - 15-nov-2009


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