Non Invasive Ventilation Comfort Study

Fisher & Paykel Healthcare

Status: Completed

Conditions: Healthy

Treatments: Device: CPAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02473068

CIA-170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Device: CPAP

Group 2

Experimental group

Description:

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:

Device: CPAP