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Ventilation with lower tidal volumes as compared to traditional tidal volumes of patients not suffering from acute lung injury
ISRCTN ISRCTN82533884
DOI 10.1186/ISRCTN82533884
ClinicalTrials.gov identifier
EudraCT number
Public title Ventilation with lower tidal volumes as compared to traditional tidal volumes of patients not suffering from acute lung injury
Scientific title
Acronym HiLoNali
Serial number at source N/A
Study hypothesis We hypothesise that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Mechanical ventilation, complications
Participants - inclusion criteria Patients who are intubated and expected to receive mechanical ventilation for greater than 72 hours are eligible for the study if they do not suffer from Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrom (ARDS), according to the American/European consensus criteria.
Participants - exclusion criteria 1. Greater than 36 hours after start of Mechnical Ventilation (MV)
2. Under 18
3. Participation in other trials
4. Pregnancy
5. Increased uncontrollable 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
Anticipated start date 01/01/2005
Anticipated end date 01/01/2007
Status of trial Completed
Patient information material
Target number of participants 200
Interventions Patients are randomly assigned to receive mechanical ventilation involving either traditional Tidal Volumes (VT) (10 ml/kg Predicted Body Weight [PBW]) or lower VT (6 ml/kg PBW). All patients will undergo a minilavage every second day, preceded by blood sampling.
Primary outcome measure(s) 1. Local inflammatory responses
2. Local Fibrin turnover
3. Systemic levels of biomarkers of lung injury
Secondary outcome measure(s) Late ALI/ARDS.
Sources of funding Not provided at time of registration
Trial website
Publications
Contact name Dr  M J  Schultz
  Address Department of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Email m.j.schultz@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address Department of Obstetrics and Gynaecology
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 20/12/2005
Last edited 18/10/2007
Date ISRCTN assigned 20/12/2005
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