Pulmonary inflammation during mechanical ventilation of patients with healthy lungs

ISRCTN ISRCTN77539853
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

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

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

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePulmonary Inflammation during mechanical ventilation of patients with healthy lungs: High tidal volumes versus Lower tidal volumes in patients with Healthy Lungs
Study acronymHiLoHelu
Study objectivesIt 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) studiedMechanical ventilation, complications
InterventionMechanical 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/11/2003
Completion date01/11/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2003
Date of final enrolment01/11/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Dept of Intensive Care
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Intensive Care
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan