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

Not Applicable

• Conditions: Non-invasive Ventilation; Healthy Volunteer; High-frequency Ventilation; Lung Diseases
• Interventions: Device: High-frequency non-invasive ventilation

• Registration Number: NCT02712190
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High - Low frequence sequence	High-frequency non-invasive ventilation	High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min
Low - High frequence sequence	High-frequency non-invasive ventilation	High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min

Primary Outcome Measures

Name	Time	Method
Duration of apnea	1 study session (2 hours)	Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de Pneumologie - Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland