Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02473068




Registration number
NCT02473068
Ethics application status
Date submitted
12/06/2015
Date registered
16/06/2015
Date last updated
5/07/2019

Titles & IDs
Public title
Non Invasive Ventilation Comfort Study
Scientific title
Non Invasive Ventilation Comfort Study
Secondary ID [1] 0 0
CIA-170
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CPAP

Active Comparator: Group 1 - In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 31°C.

Experimental: Group 2 - In random order, CPAP via a standard humidifier with chamber output temperature of 31°C, or CPAP with a prototype humidifier with chamber output temperature of 27°C.


Treatment: Devices: CPAP
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participant Comfort Questionnaire
Timepoint [1] 0 0
30 Minutes

Eligibility
Key inclusion criteria
- Any employee of FPH willing to take part in the study following review of the
Participant Information Sheet and who has provided affirmative answers to the
questions / statements included on the Consent Form
Minimum age
19 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any employee of FPH not willing to take part in the study following review of the
Participant Information Sheet.

- Any employee of FPH who has not provided affirmative answers to the questions /
statements included on the Consent Form

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/06/2019
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients who are suffering from a variety of respiratory conditions benefit from continuous
positive airway pressure (CPAP) which is a form of Non-Invasive Ventilation (NIV). Some
patients find the temperature of the breathing gas difficult to tolerate. The aim of this
study is to compare comfort of healthy volunteer participants while being given CPAP at
different temperatures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02473068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Geoff Bold, PhD
Address 0 0
Fisher & Paykel Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02473068