Pulmonary inflammation during mechanical ventilation of patients with healthy lungs

ISRCTN	ISRCTN77539853
DOI	https://doi.org/10.1186/ISRCTN77539853
Protocol serial number	NTR135
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Not provided at time of registration

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

Dr M J Schultz
Scientific

Dept of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	m.j.schultz@amc.uva.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/11/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Dept of Intensive Care

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan