Contact information
Type
Scientific
Primary contact
Dr M J Schultz
ORCID ID
Contact details
Dept of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.j.schultz@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR135
Study information
Scientific title
Pulmonary Inflammation during mechanical ventilation of patients with healthy lungs: High tidal volumes versus Lower tidal volumes in patients with Healthy Lungs
Acronym
HiLoHelu
Study hypothesis
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
Received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2003
Overall trial end date
01/11/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/11/2003
Recruitment end date
01/11/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dept of Intensive Care
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Intensive Care
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary