Ventilation with lower tidal volumes as compared to traditional tidal volumes of patients not suffering from acute lung injury

ISRCTN	ISRCTN82533884
DOI	https://doi.org/10.1186/ISRCTN82533884
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M J Schultz
Scientific

Department 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	Ventilation with lower tidal volumes as compared to traditional tidal volumes of patients not suffering from acute lung injury
Study acronym	HiLoNali
Study objectives	We hypothesise that lung protective mechanical ventilation, using lower tidal volumes, attenuates mechanical ventilation induced pulmonary inflammation.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Mechanical ventilation, complications
Intervention	Patients are randomly assigned to receive mechanical ventilation involving either traditional Tidal Volumes (VT) (10 ml/kg Predicted Body Weight [PBW]) or lower VT (6 ml/kg PBW). All patients will undergo a minilavage every second day, preceded by blood sampling.
Intervention type	Other
Primary outcome measure(s)	1. Local inflammatory responses 2. Local Fibrin turnover 3. Systemic levels of biomarkers of lung injury
Key secondary outcome measure(s)	Late ALI/ARDS.
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Total final enrolment	150
Key inclusion criteria	Patients who are intubated and expected to receive mechanical ventilation for greater than 72 hours are eligible for the study if they do not suffer from Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrom (ARDS), according to the American/European consensus criteria.
Key exclusion criteria	1. Greater than 36 hours after start of Mechnical Ventilation (MV) 2. Under 18 3. Participation in other trials 4. Pregnancy 5. Increased uncontrollable intracranial pressure 6. Severe chronic respiratory disease (daily medication) 7. Pneumonia 8. Use of corticosteroids (systemic or local) or other immunosuppressive agents 9. Pulmonary thrombo-embolism 10. After pneumonectomy or lobectomy 11. Previous randomisation in this study
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2007

Department 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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010	07/01/2021	Yes	No

07/01/2021: Publication reference and total final enrolment added.