Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001055291
Ethics application status
Approved
Date submitted
21/12/2006
Date registered
10/12/2009
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Real-time humidity measurements of expired breathe in non-invasive ventilation.
Scientific title
Randomised, cross-over comparison of humidifying load imposed on the human airway under different conditions of inspired gas in a noninvasive setting.
Secondary ID [1] 773 0
Optimal Humidity for Non-invasive ventilation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory function 2113 0
Condition category
Condition code
Respiratory 2208 2208 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 different conditions of inspired air (treatments) will be supplied to the volunteers ranging from dry air at room temperature to saturated air at 40 degC. Each participant will receive all the treatments in a randomised order.

Different conditions are:
1. 25 degC and 0% Relative Humidity (RH)
2. 25 degC and 100% RH
3. 28 degC and 100% RH
4. 32 degC and 0% RH
5. 32 degC and 100% RH
6. 37 degC and 0% RH
7. 37 degC and 50% RH
8. 37 degC and 100% RH
9. 40 degC and 0% RH
10. 40 degC and 50% RH
11. 40 degC and 100% RH

For each of the gas condition, the volunteers are asked to breathe with three different rates that are controlled by a digital blinker written in LabVIEW and a stop watch. Humidity output between oral and nasal breathing will also be studied. Each treatment will last 30 minutes and includes all 3 respiratory rates on both oral and nasal breathing. 24 hours recovering period are given between each treatment.

The study will run for 2 months and there will be no follow-up on the participants.
Intervention code [1] 1398 0
Other interventions
Comparator / control treatment
Cross-over comparison. All participants will receive all of the treatments in a randomised order.
Control group
Active

Outcomes
Primary outcome [1] 3059 0
Gas temperature, humidity and flow-rate will be continously monitored at 10 Hz. Using in-house developed laser hygrometer, K-type thermocouples and ndd Original Equipment Manufacturer (OEM) utrasonic flow-meter.

The thermodynamic response of the airway under different condition of inspired gas could potentially lead to determine the optimal level of heat and humidification
Timepoint [1] 3059 0
Immediately after each treatment
Primary outcome [2] 5229 0
Real-time humidity measurements at the mask with different conditions of inspired air and using different breathing patterns.
Timepoint [2] 5229 0
Immediately after each treatment
Secondary outcome [1] 8812 0
Thermodynamic response (temperature, pressure, flow-rate, humidity) of the human respiratory system at different conditions of inspired air.
Timepoint [1] 8812 0
Immediately after each treatment.

Eligibility
Key inclusion criteria
Volunteers must be consenting healthy males.
Minimum age
20 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cystic fibrosis or respiratory disease.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 407 0
New Zealand
State/province [1] 407 0

Funding & Sponsors
Funding source category [1] 4317 0
Commercial sector/Industry
Name [1] 4317 0
Fisher & Paykel Healthcare Ltd
Country [1] 4317 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki 2013
Auckland
Country
New Zealand
Secondary sponsor category [1] 2143 0
None
Name [1] 2143 0
none
Address [1] 2143 0
Country [1] 2143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6366 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6366 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Private Bag 92-522, Wellesley St
Auckland
Ethics committee country [1] 6366 0
New Zealand
Date submitted for ethics approval [1] 6366 0
Approval date [1] 6366 0
Ethics approval number [1] 6366 0

Summary
Brief summary
This study is to evaluate the humidifying load imposed on the human airway by inspired gas at various temperatures and humidities. The humidity response of the volunteers are measured in real-time using the infrared laser hygrometer developed by Fisher & Paykel Healthcare Ltd. (FPH).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27625 0
Address 27625 0
Country 27625 0
Phone 27625 0
Fax 27625 0
Email 27625 0
Contact person for public queries
Name 10587 0
David Liu
Address 10587 0
15 Maurice Paykel Place
East Tamaki 2013
Auckland
Country 10587 0
New Zealand
Phone 10587 0
649 5740123 ext 8222
Fax 10587 0
Email 10587 0
[email protected]
Contact person for scientific queries
Name 1515 0
David Liu
Address 1515 0
15 Maurice Paykel Place
East Tamaki 2013
Auckland
Country 1515 0
New Zealand
Phone 1515 0
649 5740123 ext 8222
Fax 1515 0
Email 1515 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
No additional documents have been identified.