No registrations found.
ID
Source
Brief title
Health condition
Patients that are scheduled for surgical procedure of > 5 hours.
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
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.
Study design
N/A
Intervention
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.
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;
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL104 |
| NTR-old | NTR135 |
| Other | : N/A |
| ISRCTN | ISRCTN77539853 |