Condition category
Respiratory
Date applied
24/10/2005
Date assigned
25/10/2005
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl

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

Publication citations

Additional files

Editorial Notes