No registrations found.
ID
Source
Brief title
Health condition
Need for prolonged mechanical ventilation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Local inflammatory responses;
2. Local Fibrin turnover;
3. Systemic levels of biomarkers of lung injury.
Secondary outcome
Late ALI/ARDS.
Background summary
Mechanical 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.
Study objective
We hypothesize that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.
Study design
N/A
Intervention
Patients 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.
Inclusion criteria
Patients 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 criteria
1. > 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.
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 | NL119 |
| NTR-old | NTR151 |
| Other | : N/A |
| ISRCTN | ISRCTN82533884 |