Non Invasive Ventilation Comfort Study | NCT02473068

Studies
Non Invasive Ventilation Comfort Study

NCT02473068

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

CPAP

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2015Actual

Primary Completion Date

Jul 1, 2016Actual

Completion Date

Jun 4, 2019Actual

First Submitted Date

Jun 12, 2015

First Submission Date that Met QC Criteria

Jun 15, 2015

First Posted Date

Jun 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2019

Last Update Posted Date

Jul 5, 2019Actual

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	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.	Device: CPAP
Group 2	Experimental	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.	Device: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device		Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Comfort Questionnaire	Participant answers questions to indicate comfort	30 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geoff Bold, PhD	Fisher & Paykel Healthcare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fisher and Paykel Healthcare		Auckland		2013	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided