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.
ID
Bron
Verkorte titel
Aandoening
Patients that are scheduled for surgical procedure of > 5 hours.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Local levels of cytokines;
<br>2. Neutrophil influx;
<br>3. Activation of coagulation/inhibition of fibrinolysis;
<br>4. Ex vivo stimulation of alveolar macrophages;
<br>5. Systemic levels of biomarkers of lung injury.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients that are scheduled for surgical procedure of > 5 hours;
2. Healthy pulmonary condition;
3. 18 years of age;
4. informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL104 |
| NTR-old | NTR135 |
| Ander register | : N/A |
| ISRCTN | ISRCTN77539853 |