We hypothesize that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.
ID
Bron
Verkorte titel
Aandoening
Need for prolonged mechanical ventilation.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Local inflammatory responses;<br>
2. Local Fibrin turnover;<br>
3. Systemic levels of biomarkers of lung injury.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
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 | NL119 |
| NTR-old | NTR151 |
| Ander register | : N/A |
| ISRCTN | ISRCTN82533884 |