Non Invasive Ventilation Comfort Study

July 1, 2019 updated by: Fisher and Paykel Healthcare
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Healthy volunteers will be given two different levels humidity and temperature and asked about preference.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 2013
        • Fisher and Paykel Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: CPAP
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.
Device: CPAP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Geoff Bold, PhD, Fisher & Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

June 4, 2019

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIA-170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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