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Trial registered on ANZCTR
Registration number
ACTRN12613000598785
Ethics application status
Not yet submitted
Date submitted
8/05/2013
Date registered
27/05/2013
Date last updated
28/05/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled study investigating neurally adjusted ventilatory assist (NAVA) application during non-invasive ventilation (NIV) in Paediatrics.
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Scientific title
The effect of neurally adjusted ventilatory assist (NAVA) application compared to standard non invasive ventilation (NIV) on length of ventilation, length of PICU stay, oxygenation and sedation requirements in paediatrics requiring NIV.
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Secondary ID [1]
282468
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NIL
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Universal Trial Number (UTN)
NIL
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Trial acronym
NIV+NAVA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory or ventilatory insufficiency
289087
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Condition category
Condition code
Respiratory
289429
289429
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Non-invasive ventilation via a mask using the neural triggering available in the mode of NAVA. Neurally Adjusted Ventilatory Assist (NAVA) is a recent highly innovative triggering design. NAVA uses an oesophageal probe which detects diaphragmatic electric activity. Diaphragmatic electric activity is the first physiological response in initiating a breath. By relying on diaphragmatic innervation the ventilator provides a timely response to patient effort that is not affected by air leaks around the face mask. The child will remain on NIV+NAVA for as long as clinically indicated.
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Intervention code [1]
287115
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Treatment: Devices
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Comparator / control treatment
Non-invasive ventilation via a mask using standard flow/pressure triggers. NIV delivered through a standard positive pressure ventilator. These ventilators rely on the patient triggering a supported breath as measured by a drop in flow within the circuit or a decrease in pressure within the circuit. The child will remain on NIV for as long as clinically indicated.
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Control group
Active
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Outcomes
Primary outcome [1]
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Length of ventilation
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Assessment method [1]
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Timepoint [1]
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This outcome will be measured when the method of delivering oxygen changes from NIV or NIV+NAVA to either high or low flow oxygen.
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Primary outcome [2]
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Oxygenation as measured by either blood gas analysis or pulse oximeter.
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Assessment method [2]
289532
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Timepoint [2]
289532
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S/F ratios are measured hourly on all enrolled patients. Many children on NIV do not have arterial access in situ to obtain blood gases for analysis. For those that do have arterial access, P/F ratios will be calculated for each sample taken throughout study period.
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Primary outcome [3]
289533
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Escalation to intubation and invasive ventilation
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Assessment method [3]
289533
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Timepoint [3]
289533
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At discharge from PICU
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Secondary outcome [1]
302695
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Patient comfort as evidenced by the amount of sedation given to the patient over the duration of the NIV respiratory support.
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Assessment method [1]
302695
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Timepoint [1]
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At discharge from PICU
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Secondary outcome [2]
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Patient safety as evidenced by the incidence of pneumothoraces, aspiration, arrest event and facial integrity.
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Assessment method [2]
302779
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Timepoint [2]
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At PICU discharge.
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Eligibility
Key inclusion criteria
Requiring respiratory support using NIV
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Minimum age
0
Days
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Facial and/or head injuries that prohibit application of the mask and strapping
2. Inability to maintain airway
3. Lack of intrinsic respiratory drive
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All children admitted to PICU that are assessed as clinically requiring NIV will be enrolled in the study. Randomisation will only occur after the clinical decision to trial NIV is made.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is computer generated.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 0
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Type of endpoint/s
Safety
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Statistical methods / analysis
In 2010-11 we treated in total 177 patients with NIV, of which 77 received only NIV, 34 initially NIV and then failed and went on to be intubated and ventilated, and 66 were supported with NIV after extubation. The population identified for this study was 111 (77 NIV only-69%, and 34 NIV followed by intubation-31%). A reduction in intubation rate by 20% would results in an intubation rate of 8%, which equates to a confidence interval 95%. Enrollment should be feasible over a 3 year period with an anticipated 366 patients treated in our unit, hence being able to recruit for the study purpose 366 patients. Data will be expressed as frequencies and percentages for categorical variables and as median or mean and standard deviation for continuous variables. A Chi-squared test will be used with odds ratio and 95% confidence interval, For non-parametric data the Mann-Whitney U test will be used. The following subgroup comparisons are pre-planned as per the patient strata: different age groups (0-6mo, 7-24mo, >24mo), cardiac versus respiratory group. All data will be managed using the SPSS (Version15) software. An ANOVA will also be conducted to compare the two groups and establish where statistically significant differences lie amongst the variables. In order to adjust for potential confounders, logistic multivariable regression will be performed with need for intubation as outcome, group allocation as a categorical variable, and potential confounders as covariables (age, sex, diagnostic group, PIM score etc). A p-value of <0.05 will be considered statistically significant.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
366
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Mater Children's Hospital
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Recruitment hospital [2]
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Royal Children's Hospital - Herston
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Recruitment postcode(s) [1]
6830
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4101 - South Brisbane
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Recruitment postcode(s) [2]
6831
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4006 - Herston
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Funding & Sponsors
Funding source category [1]
287249
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Charities/Societies/Foundations
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Name [1]
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Golden Casket
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Address [1]
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Mater Foundation
Stanley St
South Brisbane, QLD, 4101
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Mater Children's Hospital
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Address
Mater Health Services
PICU
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
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Country
Australia
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Secondary sponsor category [1]
286000
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None
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Name [1]
286000
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Address [1]
286000
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Country [1]
286000
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
289228
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Mater Health Services
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Ethics committee address [1]
289228
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Aubigny Place
Mater Health Services
Raymond Terr
South Brisbane, QLD, 4101
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Ethics committee country [1]
289228
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Australia
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Date submitted for ethics approval [1]
289228
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01/04/2013
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Approval date [1]
289228
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Ethics approval number [1]
289228
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C1952C
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Summary
Brief summary
Non-invasive ventilation (NIV) as a mode of respiratory support is growing in poopularity and a number of studies have demonstrated it's benefit in both adults and children. Difficulties associated with NIV are largely attributed to leakage around the mask which adversely affects triggering and results in a time lag between patient effort and the ventilator's response. Neurally adjusted ventilatory assist (NAVA) uses an oesophageal probe which detects diaphragmatic innervation for every breath. This results in a much more timely co-ordination of ventilatory support.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Andreas Schibler
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Address
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Consultant Intensivist
Paediatric Intensive Care Unit
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
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Country
39882
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Australia
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Phone
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+61731632752
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Fax
39882
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jacqui Jauncey-Cooke
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Address
39883
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Clinical Nurse Researcher
Paediatric Intensive Care Unit
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
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Country
39883
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Australia
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Phone
39883
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+61731631143
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Fax
39883
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Email
39883
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Andreas Schibler
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Address
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PICU - Level 5
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
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Country
39884
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Australia
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Phone
39884
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+61731632752
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Fax
39884
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Email
39884
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[email protected]
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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.
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