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Trial registered on ANZCTR


Registration number
ACTRN12610000886088
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
19/10/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pressure limit selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial
Scientific title
Pressure limit selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial
Secondary ID [1] 252879 0
None
Universal Trial Number (UTN)
Trial acronym
AC/VG Pmax Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal ventilation 258410 0
Condition category
Condition code
Respiratory 258576 258576 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 258615 258615 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ventilator pressure limit settings will be compared in random order. The intervention periods (epochs) will last for 20 mins. Each epoch will be preceded by a 10 minute washout period. Infants will be ventilated using assist control volume guarantee mode with the Drager Babylog 8000plus ventilator throughout the study.

The following selection methods will be compared:
[A] The current standard setting in the neonatal intensive care unit (30 cm H2O)
[B] A setting based upon the average delivered PIP for triggered inflations (identified by the researcher) + 5 cm H2O
[C] A setting based upon the perceived 'working PIP' (as reported by the staff caring for the baby) + 5 cm H2O
Intervention code [1] 257406 0
Treatment: Devices
Comparator / control treatment
See description of interventions
Control group
Active

Outcomes
Primary outcome [1] 259422 0
Proportion of ventilator inflations with expired tidal volume with 90-110% of target tidal volume, identified from the ventilator waveforms/trigger data
Timepoint [1] 259422 0
These data are measured continually. The outcome is defined as the number of inflations in range / total number of inflations over the epoch
Secondary outcome [1] 265970 0
Ventilator parameters determined from the ventilator data including:
Rate, mean airway pressure, peak inflating pressure
Timepoint [1] 265970 0
The data are measure continually over the epoch. Epoch averages will be compared
Secondary outcome [2] 265971 0
Measures of cardiorespiratory stability including:
FiO2, SpO2, TcCO2, HR and BP assessed using the ventilator data, Masimo Radical pulse oximeter, and Philips Intellivue series monitor with transcutaneous module
Timepoint [2] 265971 0
These data are recorded every minute. The change over the epoch will be measured (average data from last 2 mins of epoch minus average data from last 2 mins of run in period prior to epoch)

Eligibility
Key inclusion criteria
Stable ventilated infants, ventilated using assist control volume guarantee (AC/VG) for previous 24 hours.
Minimum age
24 Hours
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ventilator changes in previous 4 hours, pH < 7.2, pCO2>80 mmHg, FiO2 > 0.8, acute pneumothoax/pulmonary interstitial emphysema, significant congenital abnormality, severe PVH, receiving muscle relaxants or morphine infusion > 20 ug/kg/hr

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised crossover trial. Allocation of order of interventions using sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257844 0
Government body
Name [1] 257844 0
NMHRC
Address [1] 257844 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 257844 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Locked Bag 300
Cnr Grattan Street/Flemington Road
Parkville
Vic 3052
Country
Australia
Secondary sponsor category [1] 257051 0
None
Name [1] 257051 0
Address [1] 257051 0
Country [1] 257051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259880 0
The Royal Womens Hospital Research and Ethics Committees
Ethics committee address [1] 259880 0
Locked Bag 300
Cnr Grattan St/Flemington Road
Parkville
Vic 3052
Ethics committee country [1] 259880 0
Australia
Date submitted for ethics approval [1] 259880 0
29/11/2007
Approval date [1] 259880 0
10/01/2008
Ethics approval number [1] 259880 0
Project 07/33

Summary
Brief summary
The purpose of this project is to study how ventilators (breathing machines) support babies. We are investigating how we use the ventilator with the aim of better matching the babies' natural breathing patterns.

The ventilator can vary the pressure it uses to adjust to your baby’s breathing. We set a maximum inflation pressure limit for how high it can go. Previous experience suggests that this having this limit set higher means babies can get a mixture of higher and lower pressures which may irritate some babies. Setting the limit lower means the ventilation pressures are more even. If the ventilator senses that the pressure limit is too low it will sound an alarm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31778 0
Address 31778 0
Country 31778 0
Phone 31778 0
Fax 31778 0
Email 31778 0
Contact person for public queries
Name 15025 0
Kevin Wheeler
Address 15025 0
Newborn Research
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street/Flemington Road
Parkville
Vic 3052
Country 15025 0
Australia
Phone 15025 0
+61 3 8345 2000
Fax 15025 0
Email 15025 0
kevin.wheeler@thewomens.org.au
Contact person for scientific queries
Name 5953 0
Kevin Wheeler
Address 5953 0
Newborn Research
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street/Flemington Road
Parkville
Vic 3052
Country 5953 0
Australia
Phone 5953 0
+61 3 8345 2000
Fax 5953 0
Email 5953 0
kevin.wheeler@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary