Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000549022
Ethics application status
Approved
Date submitted
7/07/2010
Date registered
8/07/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the work of breathing of children receiving nasal high flow oxygen
Scientific title
Assessment of pharyngeal pressure and work of breathing in children on nasal high flow oxygen
Secondary ID [1] 252169 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress 257713 0
Condition category
Condition code
Respiratory 257881 257881 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement of pharyngeal pressure and work of breathing of children receiving nasal high flow oxygen over a period of one to two hours.

For those children on low flow oxygen, measurements will be made on low flow. High flow nasal cannulae will be applied, and flow applied at 1L/kg/min, then 2L/kg/min, then 3L/kg/min, then 4L/kg/min. Measurements will be taken after 10 minutes on each flow rate. Before increasing to a new flow rate, flow will be decreased to 1L/kg/min for 2 minutes. The flow will be delivered to a maximum of 60L/minute.

For children already receiving nasal high flow oxygen, the measurements will be made on high flow oxygen, then on low flow oxygen at 2L/minute if deemed safe by the treating team.

Children on continuous positive airways pressure (CPAP) will have nasal high flow oxygen prongs applied, then will have the measurements made as above.
Intervention code [1] 256767 0
Treatment: Devices
Comparator / control treatment
Patients act as own control comparing the pressures generated and work of breathing each high flow oxgyen flow rate to the pressure and work of breathing on low flow oxygen.
Control group
Active

Outcomes
Primary outcome [1] 258747 0
Pharyngeal pressure measured with a polyurethane air filled catheter inserted into the nasopharynx attached to the Bicore II device for measurement.
Timepoint [1] 258747 0
Over a duration of one to two hours while receiving nasal high flow oxygen (NHFO2). Measurements made every 12 minutes.
Secondary outcome [1] 264796 0
Work of breathing calculated from oesophageal pressure measured by oesophageal catheter with air filled pressure balloon inserted nasogastrically or orogastrically, and lung volume change measured by respiratory inductance plesmography bands around the thorax and abdomen. Both measurements made with the Bicore II device.
Timepoint [1] 264796 0
Over a duration of one to two hours while receiving nasal high flow oxygen (NHFO2). Measurements made every 12 minutes.

Eligibility
Key inclusion criteria
Respiratory distress (either primary or secondary) who
are receiving nasal high flow oxygen or continuous positive airways pressure; or require greater than or equal to 2L/min of oxygen via nasal prongs, and have at least moderate work of breathing as determined by the treating team
Minimum age
0 Days
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who require intubation and invasive ventilation.
Children with a contraindication to nasal canulae and non invasive ventilation

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
Crossover
Other design features
All patients treated with the same protocol
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2752 0
New Zealand
State/province [1] 2752 0
Auckland

Funding & Sponsors
Funding source category [1] 257262 0
Commercial sector/Industry
Name [1] 257262 0
Fisher and Paykel Healthcare
Country [1] 257262 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jan Kelly
Address
Level 2, Building 2
Private Bag 92024
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256506 0
Individual
Name [1] 256506 0
Dr John Beca
Address [1] 256506 0
Level 2, Building 2
Private Bag 92024
Auckland 1142
Country [1] 256506 0
New Zealand
Other collaborator category [1] 251376 0
Individual
Name [1] 251376 0
Dr David Buckley
Address [1] 251376 0
Level 2, Building 2
Private Bag 92024
Auckland 1142
Country [1] 251376 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259280 0
Northern X Ethics Committee
Ethics committee address [1] 259280 0
Private Bag 92-522, Wellesley St
Auckland 1142
Ethics committee country [1] 259280 0
New Zealand
Date submitted for ethics approval [1] 259280 0
Approval date [1] 259280 0
21/01/2010
Ethics approval number [1] 259280 0
NTX/09/10/091

Summary
Brief summary
Children/Tamariki with lung problems often need help with their breathing. There are several ways of doing this, but the problem with the current methods is that they involve uncomfortable straps on the face which children/Tamariki do not like.

We have a new and better-tolerated method of delivering oxygen, which helps babies and children/ Tamariki breathe more easily. It uses nasal “prongs” very similar to that used for standard oxygen delivery but modified to be able to use a faster flow of oxygen. It has been used successfully in babies and children/Tamariki worldwide. We would like to better understand how this treatment works and how best to adjust it for individual patients.

We will give different flow rates of oxygen and measure how much easier it is for the child/Tamariki to breathe. To do this we use a modified feeding tube, a very fine tube in the nose to measure the pressure there, loosely apply stretchy bands to the chest and abdomen to measure breathing, and we stick a dot to the skin to measure gas levels. These have minimal risk. This work will help us determine how much oxygen is best for each child/Tamariki.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31372 0
Address 31372 0
Country 31372 0
Phone 31372 0
Fax 31372 0
Email 31372 0
Contact person for public queries
Name 14619 0
Dr Jan Kelly
Address 14619 0
Level 2 Building 2
Private Bag 92024
Auckland 1142
Country 14619 0
New Zealand
Phone 14619 0
+64 9 3074903
Fax 14619 0
Email 14619 0
[email protected]
Contact person for scientific queries
Name 5547 0
Dr Jan Kelly
Address 5547 0
Level 2 Building 2
Private Bag 92024
Auckland 1142
Country 5547 0
New Zealand
Phone 5547 0
+64 9 3074903
Fax 5547 0
Email 5547 0
[email protected]

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
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