Non Invasive Ventilation Comfort Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: CPAP

• Registration Number: NCT02473068
• Lead Sponsor: Fisher and Paykel Healthcare

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

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 Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-16
• Study Start: 2015-06-19
• Primary Completion: 2016-07-01
• Status Verified: 2019-06
• Study Completion: 2019-06-04
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	CPAP	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.
Group 1	CPAP	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.

Primary Outcome Measures

Name	Time	Method
Participant Comfort Questionnaire	30 Minutes	Participant answers questions to indicate comfort

Trial Locations

Locations (1)

Fisher and Paykel Healthcare; 🇳🇿 Auckland, New Zealand