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

Healthy Volunteer Clinical Trial

— ANIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02712190
• Other study ID #: ANIV
• Status: Recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 2022

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Alban Lovis, MD
• Email: alban.lovis[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer
• High-frequency Ventilation
• Lung Diseases
• Non-invasive Ventilation

Intervention

Device:
• High-frequency non-invasive ventilation
Comparison of 2 different settings of HF-NIV

Locations

Country	Name	City	State
Switzerland	Service de Pneumologie - Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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