search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Pulmonary Inflammation during Mechanical Ventilation of Patients with Healthy Lungs.


- candidate number1224
- NTR NumberNTR135
- ISRCTNISRCTN77539853
- Date ISRCTN created25-okt-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsN/A 
- Public TitlePulmonary Inflammation during Mechanical Ventilation of Patients with Healthy Lungs.
- Scientific TitlePulmonary Inflammation during Mechanical Ventilation of Patients with Healthy Lungs. -HIgh tidal volumes versus LOwer tidal volumes in patients with HEalthy LUngs-
- ACRONYMHiLoHelu
- hypothesisIt 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) studiedMechanical ventilation, complications
- Inclusion criteria1. Patients that are scheduled for surgical procedure of > 5 hours;
2. Healthy pulmonary condition;
3. 18 years of age;
4. informed consent.
- Exclusion criteria1. Sepsis or uncontrolled infection;
2. ALI/ARDS;
3. Pneumonia;
4. Steroid-use;
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;
10. Pneumonectomy/lebectomy;
11. Participation in another trial;
12. Previous randomisation in present trial.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2003
- planned closingdate1-nov-2005
- Target number of participants40
- InterventionsMechanical 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 outcome1. 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 outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schultz
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Department of Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsAnesthesiology. 2008 Jan;108(1):46-54.
- Brief summaryLung 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)
- RECORD16-aug-2005 - 15-sep-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl