Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung disease.

Detailed Description
-----------------
High frequency ventilation (HF-V) allows to ensure oxygen delivery and carbon dioxide clearance despite the absence of thoracic movement in anesthetized, invasively ventilated subjects. This same technique could be applied by a non-invasive interface (HF-NIV), allowing to obtain a prolonged apnea (absence of thoraco-abdominal respiratory movements) in awaken subjects. Such an application would be of interest for several clinical applications, e.g. lung imaging and radio-therapy treatment on lung cancer. The purpose of the study is to assess the effect of different HF-NIV setting on the apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung diseases.

Official Title
-----------------
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.

Conditions
-----------------
Non-invasive Ventilation, High-frequency Ventilation, Healthy Volunteer, Lung Diseases

Intervention / Treatment
-----------------
* Device: High-frequency non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjets : normal respiratory function and no known lung disease lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis age >=18y Exclusion Criteria: increased pneumothorax risk under positive pressure ventilation pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low - High frequence sequence<br>High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min | Device: High-frequency non-invasive ventilation<br>* Comparison of 2 different settings of HF-NIV<br>* Other names: HF-NIV;|
| Experimental: High - Low frequence sequence<br>High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min | Device: High-frequency non-invasive ventilation<br>* Comparison of 2 different settings of HF-NIV<br>* Other names: HF-NIV;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of apnea | Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements | 1 study session (2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous carbon dioxide partial pressure | Evolution of transcutaneous carbon dioxide partial pressure (TcCo2) | 1 study session (2 hours) | 
| Oxygen saturation of arterial blood | Evolution of oxygen saturation, measured by pulse-oximetry (SatO2) | 1 study session (2 hours) | 
| Lung volume | Evolution of lung volume | 1 study session (2 hours) | 
| Subjective tolerance | Subjective tolerance of the HF-NIV (questionnaire) | 1 study session (2 hours) |