Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000552088
Ethics application status
Approved
Date submitted
8/07/2010
Date registered
9/07/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising Lung Volume in Children/Tamariki Ventilated for Lung Problems
Scientific title
Using Changes in Pulmonary Mechanics and Gas Exchange to Better Define the Optimal Pulmonary Volume in Children/Tamariki Ventilated for Acute Lung Injury.
Secondary ID [1] 252168 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lung injury 257711 0
Acute Respiratory Distress Syndrome (ARDS) 257712 0
Condition category
Condition code
Respiratory 257880 257880 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement of transpulmonary pressure during stepped positive end expiratory pressure (PEEP) recuitment manoever on conventional mandatory ventilation (CMV) and high frequency oscillatory ventilation (HFOV). Children with severe ARDS will only be studied on HFOV.

Recruitment strategy - CMV. Tidal volume 6ml/kg with a rate enabling adequate carbon dioxide (CO2) clearance without autoPEEP. Inspired fraction of oxygen (FiO2) to permit oxygen saturation 85-92% in neonates and 92-96% in older children. PEEP commenced at 5cmH2O. PEEP increased in increments of 2cm H2O at short intervals. Each step held until an oxygenation plateau is achieved. Measurements made at the end of each step. PEEP increased until oxygenation improves (the opening pressure).

The lung will be considered recruited when either the FiO2 can be reduced to <0.4, or there are signs of overdistension. The PEEP will then be reduced in steps of 1cmH2O allowing plateauing of oxygenation and transcutaneous carbon dioxide [TcCO2] with measurement at the end of each step. The PEEP will be reduced until there is a significant reduction in oxygenation, compliance, or increase in TcCO2 (the closing pressure).

Lung recruitment on HFOV will be performed with a frequency (Hertz) and amplitude appropriate for age and illness severity, and allowing adequate CO2 clearance. An FiO2 to permit previously described oxygen saturation parameters will be used.

The mean airways pressure (MAP) will be commenced at 10cmH20, or at four above the MAP on CMV if previously CMV ventilated. The MAP will be increased and then decreased in steps of 2cmH2O as described above.

The lung will then be recruited by increasing the PEEP / MAP to the previously noted opening pressure, then the PEEP / MAP will be reduced to 2cm above the closing pressure.

The duration of the both the entire recruitment manoever and duration and number of individual steps will vary between patients, as the time to plateau at each step varies both between patients and with the lung pathology. The entire procedure takes between one and three hours.
Intervention code [1] 256765 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258746 0
Measurement of the transpulmonary pressure (TPP). TPP calculated from oesophageal pressure measured using a nasogastric or orgastric tube with air filled oesophageal catheter, and lung volume change measured using respiratory inductance plethymography (one thoracic and one abdominal band). Both measurements made by the Bicore II device.
Timepoint [1] 258746 0
Measurements are made during the stepped PEEP recruitment manoever. Measurements are made at the end of each PEEP / MAP step after stabilisation of oxygenation and TcCO2.
Primary outcome [2] 258752 0
Comparison of the transpulmonary pressure (TPP) with other measures indicating the open lung state (oxygenation, carbon dioxide clearance measured by transcutaneous carbon dioxide, lung compliance during conventional ventilation).
Timepoint [2] 258752 0
Measurements are made during the stepped PEEP recruitment manoever. Measurements are made at the end of each PEEP / MAP step after stabilisation of oxygenation and TcCO2.
Secondary outcome [1] 264795 0
Comparison of two groups- direct and indirect lung injury during stepped PEEP recruitment over a period of one to three hours.
Timepoint [1] 264795 0
Measurements are made during the stepped PEEP recruitment manoever. Measurements are made at the end of each PEEP / MAP step after stabilisation of oxygenation and TcCO2.

Eligibility
Key inclusion criteria
Mechanically ventilated.
Lung pathology fulfilling criteria for acute lung injury or acute respiratory distress syndrome.
Minimum age
0 Days
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children ventilated for an obstructive lung pathology.
Children with raised intracranial pressure or a head injury.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All patients follow same protocol.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2749 0
Switzerland
State/province [1] 2749 0
Country [2] 2750 0
New Zealand
State/province [2] 2750 0
Country [3] 2751 0
Netherlands
State/province [3] 2751 0

Funding & Sponsors
Funding source category [1] 257261 0
Commercial sector/Industry
Name [1] 257261 0
CareFusion
Country [1] 257261 0
Netherlands
Primary sponsor type
Individual
Name
Dr Jan Kelly
Address
Starship Children's Health
Private Bag 92024
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256504 0
Individual
Name [1] 256504 0
Dr Peter Rimensberger
Address [1] 256504 0
Geneva Children's Hospital, University Hospital
of Geneva, Rue Willy-Donze 6
CH1211 Geneva 14
Country [1] 256504 0
Switzerland
Other collaborator category [1] 251372 0
Individual
Name [1] 251372 0
Dr John Beca
Address [1] 251372 0
Starship Children's Health
Private Bag 92024
Auckland 1142
Country [1] 251372 0
New Zealand
Other collaborator category [2] 251373 0
Individual
Name [2] 251373 0
Dr Dick Markhorst
Address [2] 251373 0
Department of Paediatric Intensive Care
VU University Medical Center
P.O. Box 7057, 1007 MB, Amsterdam
The Netherlands
Country [2] 251373 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259277 0
Northern X Ethics Committee
Ethics committee address [1] 259277 0
Ethics committee country [1] 259277 0
New Zealand
Date submitted for ethics approval [1] 259277 0
Approval date [1] 259277 0
03/02/2009
Ethics approval number [1] 259277 0
NTX/12/08/124
Ethics committee name [2] 259278 0
Geneva Maternity and Paediatric Departmental Ethics Committee
Ethics committee address [2] 259278 0
Ethics committee country [2] 259278 0
Switzerland
Date submitted for ethics approval [2] 259278 0
Approval date [2] 259278 0
30/10/2007
Ethics approval number [2] 259278 0
1/07/0033
Ethics committee name [3] 259279 0
Amsterdam Ethics Committee
Ethics committee address [3] 259279 0
Ethics committee country [3] 259279 0
Netherlands
Date submitted for ethics approval [3] 259279 0
Approval date [3] 259279 0
14/10/2008
Ethics approval number [3] 259279 0
2008/190

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31371 0
Address 31371 0
Country 31371 0
Phone 31371 0
Fax 31371 0
Email 31371 0
Contact person for public queries
Name 14618 0
Dr Jan Kelly
Address 14618 0
Starship Children's Health
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 14618 0
New Zealand
Phone 14618 0
+6493074903
Fax 14618 0
Email 14618 0
janke@adhb.govt.nz
Contact person for scientific queries
Name 5546 0
Dr Jan Kelly
Address 5546 0
Starship Children's Health
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 5546 0
New Zealand
Phone 5546 0
+6493074903
Fax 5546 0
Email 5546 0
janke@adhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.