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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.
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.
Secondary ID [1] 282468 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIV+NAVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory or ventilatory insufficiency 289087 0
Condition category
Condition code
Respiratory 289429 289429 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287115 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 289531 0
Length of ventilation
Timepoint [1] 289531 0
This outcome will be measured when the method of delivering oxygen changes from NIV or NIV+NAVA to either high or low flow oxygen.
Primary outcome [2] 289532 0
Oxygenation as measured by either blood gas analysis or pulse oximeter.
Timepoint [2] 289532 0
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.
Primary outcome [3] 289533 0
Escalation to intubation and invasive ventilation
Timepoint [3] 289533 0
At discharge from PICU
Secondary outcome [1] 302695 0
Patient comfort as evidenced by the amount of sedation given to the patient over the duration of the NIV respiratory support.
Timepoint [1] 302695 0
At discharge from PICU
Secondary outcome [2] 302779 0
Patient safety as evidenced by the incidence of pneumothoraces, aspiration, arrest event and facial integrity.
Timepoint [2] 302779 0
At PICU discharge.

Eligibility
Key inclusion criteria
Requiring respiratory support using NIV
Minimum age
0 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is computer generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
366
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 974 0
Mater Children's Hospital
Recruitment hospital [2] 976 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 6830 0
4101 - South Brisbane
Recruitment postcode(s) [2] 6831 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 287249 0
Charities/Societies/Foundations
Name [1] 287249 0
Golden Casket
Country [1] 287249 0
Australia
Primary sponsor type
Hospital
Name
Mater Children's Hospital
Address
Mater Health Services
PICU
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 286000 0
None
Name [1] 286000 0
Address [1] 286000 0
Country [1] 286000 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289228 0
Mater Health Services
Ethics committee address [1] 289228 0
Ethics committee country [1] 289228 0
Australia
Date submitted for ethics approval [1] 289228 0
01/04/2013
Approval date [1] 289228 0
Ethics approval number [1] 289228 0
C1952C

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

Contacts
Principal investigator
Name 39882 0
A/Prof Andreas Schibler
Address 39882 0
Consultant Intensivist
Paediatric Intensive Care Unit
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
Country 39882 0
Australia
Phone 39882 0
+61731632752
Fax 39882 0
Email 39882 0
andreas.schibler@mater.org.au
Contact person for public queries
Name 39883 0
Jacqui Jauncey-Cooke
Address 39883 0
Clinical Nurse Researcher
Paediatric Intensive Care Unit
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
Country 39883 0
Australia
Phone 39883 0
+61731631143
Fax 39883 0
Email 39883 0
jacqui.jauncey-cooke@mater.org.au
Contact person for scientific queries
Name 39884 0
Andreas Schibler
Address 39884 0
PICU - Level 5
Mater Children's Hospital
Raymond Terr
South Brisbane, QLD, 4101
Country 39884 0
Australia
Phone 39884 0
+61731632752
Fax 39884 0
Email 39884 0
andreas.schibler@mater.org.au

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.