|- candidate number||1224|
|- NTR Number||NTR135|
|- Date ISRCTN created||25-okt-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||23-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Pulmonary Inflammation during Mechanical Ventilation of Patients with Healthy Lungs.|
|- Scientific Title||Pulmonary Inflammation during Mechanical Ventilation of Patients with Healthy Lungs.
-HIgh tidal volumes versus LOwer tidal volumes in patients with HEalthy LUngs-|
|- hypothesis||It is hypothesized that mechanical ventilation using lower tidal volumes and PEEP causes less local inflammation in patients with healthy lungs than mechanical ventilation using traditional tidal volumes and no PEEP.|
|- Healt Condition(s) or Problem(s) studied||Mechanical ventilation, complications|
|- Inclusion criteria||1. Patients that are scheduled for surgical procedure of > 5 hours;
2. Healthy pulmonary condition;
3. 18 years of age;
4. informed consent.
|- Exclusion criteria||1. Sepsis or uncontrolled infection;
5. Diagnosis of asthma;
6. Pulmonary fibrosis;
7. Current thrombo-embolism;
8. On daily medication for COPD;
9. Mechanical ventilation for > 48 hours in the month prior to surgery;
11. Participation in another trial;
12. Previous randomisation in present trial.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2003|
|- planned closingdate||1-nov-2005|
|- Target number of participants||40|
|- Interventions||Mechanical ventilation using lower tidal volumes (6 ml/kg) and 10 cm H2O PEEP versus mechanical ventilation using traditional tidal volumes (12 ml/kg) and no PEEP. Broncholaveoalr lavage at T = 0 and at T = 5 hours.|
|- Primary outcome||1. Local levels of cytokines;
2. Neutrophil influx;
3. Activation of coagulation/inhibition of fibrinolysis;
4. Ex vivo stimulation of alveolar macrophages;
5. Systemic levels of biomarkers of lung injury.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.J. Schultz|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.J. Schultz|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Intensive Care|
(Source(s) of Monetary or Material Support)
|- Publications||Anesthesiology. 2008 Jan;108(1):46-54.|
|- Brief summary||Lung protective mechanical ventilation, using lower tidal volumes and sufficient levels of PEEP has been shown to be beneficial for patients with ALI or ARDS.|
It is hypothesized that mechanical ventilation using lower tidal volumes and PEEP causes less local inflammation in patients with healthy lungs than mechanical ventilation using traditional tidal volumes and no PEEP.
For this, 40 patients with healhy lungs are randomized to be either mecahnically ventilated with a so-called protective strategy or with a conventional strategy.
|- Main changes (audit trail)|
|- RECORD||16-aug-2005 - 15-sep-2008|