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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02712190
Acronym
ANIV
Enrollment
30
Registered
2016-03-18
Start date
2016-03-31
Completion date
2022-09-30
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEHigh-frequency non-invasive ventilation

Comparison of 2 different settings of HF-NIV

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of apnea1 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

MeasureTime frameDescription
Transcutaneous carbon dioxide partial pressure1 study session (2 hours)Evolution of transcutaneous carbon dioxide partial pressure (TcCo2)
Oxygen saturation of arterial blood1 study session (2 hours)Evolution of oxygen saturation, measured by pulse-oximetry (SatO2)
Lung volume1 study session (2 hours)Evolution of lung volume
Subjective tolerance1 study session (2 hours)Subjective tolerance of the HF-NIV (questionnaire)

Countries

Switzerland

Contacts

Primary ContactAlban Lovis, MD
alban.lovis@chuv.ch
Backup ContactAdam Ogna, MD
adam.ogna@chuv.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026