Pulmonary inflammation during mechanical ventilation of patients with healthy lungs
ISRCTN | ISRCTN77539853 |
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DOI | https://doi.org/10.1186/ISRCTN77539853 |
Secondary identifying numbers | NTR135 |
- Submission date
- 24/10/2005
- Registration date
- 25/10/2005
- Last edited
- 05/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M J Schultz
Scientific
Scientific
Dept of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.j.schultz@amc.uva.nl |
Study information
Study design | Randomised, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Pulmonary Inflammation during mechanical ventilation of patients with healthy lungs: High tidal volumes versus Lower tidal volumes in patients with Healthy Lungs |
Study acronym | HiLoHelu |
Study objectives | It is hypothesised that mechanical ventilation using lower tidal volumes and positive end expiratory pressure (PEEP) causes less local inflammation in patients with healthy lungs than mechanical ventilation using traditional tidal volumes and no PEEP. |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Mechanical ventilation, complications |
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. Broncholaveolar lavage at T = 0 and at T = 5 hours |
Intervention type | Other |
Primary outcome measure | 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 measures | No secondary outcome measures |
Overall study start date | 01/11/2003 |
Completion date | 01/11/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 40 |
Key inclusion criteria | 1. Patients that are scheduled for surgical procedure of greater than 5 hours 2. Healthy pulmonary condition 3. 18 years of age 4. Informed consent |
Key exclusion criteria | 1. Sepsis or uncontrolled infection 2. Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) 3. Pneumonia 4. Steroid-use 5. Diagnosis of asthma 6. Pulmonary fibrosis 7. Current thrombo-embolism 8. On daily medication for chronic obstructive pulmonary disease (COPD) 9. Mechanical ventilation for greater than 48 hours in the month prior to surgery 10. Pneumonectomy/lebectomy 11. Participation in another trial 12. Previous randomisation in present trial |
Date of first enrolment | 01/11/2003 |
Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dept of Intensive Care
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Intensive Care
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Website | http://www.amc.uva.nl |
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https://ror.org/03t4gr691 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |