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Trial registered on ANZCTR


Registration number
ACTRN12605000798662
Ethics application status
Approved
Date submitted
19/12/2005
Date registered
20/12/2005
Date last updated
14/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the effectiveness of an oxygen delivery system.
Scientific title
Evaluation of the Fisher and Paykel high flow humidified nasal interface system by the measurement of hypopharyngeal inspired oxygen fraction and airway pressures in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 957 0
Condition category
Condition code
Respiratory 1026 1026 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A study to find the flow rate which enables the delivery of a desired inspired oxygen fraction (FiO2) in healthy volunteers.
Each participant will have a nasopharyngeal catheter inserted, then they will be started on oxygen through the Fisher and Paykel high flow humidified nasal interface system (MR880, RT241, RT033/034).
FiO2 at different flow rates will be calculated from measured end expired oxygen (FETO2) and carbon dioxide (FETO2) fractions.
Measurements will be made at rest with quiet breathing both for mouth and nose breathing and then repeated with exercise.
Intervention code [1] 3858 0
Not applicable
Comparator / control treatment
Patients act as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1376 0
FETO2 at different flow rates.
Timepoint [1] 1376 0
Sampled continuously via the naso-hypopharyngeal catheter.
Primary outcome [2] 1377 0
FETCO2 at different flow rates.
Timepoint [2] 1377 0
Sampled continuously via the naso-hypopharyngeal catheter.
Secondary outcome [1] 2439 0
Secondary outcomes include heart rate, blood pressure and respiratory rate.
Timepoint [1] 2439 0
These will be measured continuously and correlated to changes in flow rates.

Eligibility
Key inclusion criteria
Fit Healthy Adult Volunteers.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy. 2. Abnormal upper airway anatomy. 3. Recent (within 1 week) or current upper or lower respiratory tract infection. 4. Chronic respiratory illness. 5. Any medical condition precluding the ability to exercise eg. exercise induced asthma, ischaemic heart disease, hypertrophic obstructive cardiomyopathy.

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
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 outside Australia
Country [1] 251 0
New Zealand
State/province [1] 251 0

Funding & Sponsors
Funding source category [1] 1129 0
Commercial sector/Industry
Name [1] 1129 0
Fisher and Paykel Healthcare
Address [1] 1129 0
15 Maurice Paykel Place. East Tamaki. Auckland
Country [1] 1129 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place. East Tamaki. Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 986 0
None
Name [1] 986 0
N/A
Address [1] 986 0
Country [1] 986 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
It is likely that high flow nasal systems are able to deliver a more constant and reliable FiO2 than traditional methods.
Our proposed method of measurement of FiO2 is through the insertion of a nasopharyngeal catheter and continuous measurement of end expired oxygen (FETO2) and carbon dioxide (FETCO2) fractions.
Measurements of FiO2 will be made with increasing gas flow rates, inspiratory flow rate (with exercise) and during mouth and nose breathing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35259 0
Address 35259 0
Country 35259 0
Phone 35259 0
Fax 35259 0
Email 35259 0
Contact person for public queries
Name 9997 0
Catherine Gerard
Address 9997 0
Fisher and Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki Auckland 1706
Country 9997 0
New Zealand
Phone 9997 0
+64 9 5740100
Fax 9997 0
Email 9997 0
catherine.gerard@fphcare.co.nz
Contact person for scientific queries
Name 925 0
Dr Joanne Ritchie
Address 925 0
Department of Intensive Care Medicine
Middlemore Hospital
Private Bag Otahuhu
Auckland
Country 925 0
New Zealand
Phone 925 0
+64 9 2760112
Fax 925 0
Email 925 0
RitchiJ@middlemore.co.nz

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