Non Invasive Ventilation Comfort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-19

Study Completion Date

2019-06-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Interventions

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CPAP

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes