Non-invasive VentilationANIVNCT02712190
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
A study testing High-frequency non-invasive ventilation in people with Non-invasive Ventilation and High-frequency Ventilation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Ventilation, High-frequency Ventilation, Healthy Volunteer
- What is being tested?
- High-frequency non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjets : normal respiratory function and no known lung disease
- lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis
- age >=18y
Who cannot join
- increased pneumothorax risk under positive pressure ventilation
- pregnancy
Trial locations and contacts
1 site in 1 country.
Alban Lovis, MD contact
Adam Ogna, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Service de Pneumologie - Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Alban Lovis, MD, alban.lovis@chuv.ch
Adam Ogna, MD, adam.ogna@chuv.ch
About this study
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.
Read the 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.
- Being tested
- High-frequency non-invasive ventilation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency non-invasive ventilationDevice
Also called HF-NIV
Comparison of 2 different settings of HF-NIV
| Study group | Role | What they receive |
|---|---|---|
| Low - High frequence sequence | Experimental | High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min Receives: Device: High-frequency non-invasive ventilation |
| High - Low frequence sequence | Experimental | High-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min Receives: Device: High-frequency non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of apnea
Duration of apnea according to the different settings of the HF-NIV, defined as absence of thoraco-abdominal respiratory movements
Measured: 1 study session (2 hours)
Secondary outcomes (4)
Transcutaneous carbon dioxide partial pressure
Evolution of transcutaneous carbon dioxide partial pressure (TcCo2)
Measured: 1 study session (2 hours)
Oxygen saturation of arterial blood
Evolution of oxygen saturation, measured by pulse-oximetry (SatO2)
Measured: 1 study session (2 hours)
Lung volume
Evolution of lung volume
Measured: 1 study session (2 hours)
Subjective tolerance
Subjective tolerance of the HF-NIV (questionnaire)
Measured: 1 study session (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive VentilationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Ogna, Centre Hospitalier Universitaire Vaudois
- Investigators
- Alban Lovis, Principal investigator, Service de Pneumologie - CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712190
- Sponsor's protocol ID
- ANIV
- Acronym
- ANIV
- Status last verified
- Aug 2020
- First submitted
- 10 Mar 2016
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.
- ClinicalTrials.gov ID
- NCT02712190
- Acronym / sponsor ID
- ANIV / ANIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low - High frequence sequence | Experimental | Device: High-frequency non-invasive ventilationHigh-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 250/min and respiratory rate 500/min |
| High - Low frequence sequence | Experimental | Device: High-frequency non-invasive ventilationHigh-Frequency non-invasive ventilation (HF-NIV) with 2 different settings, sequence of respiratory rate 500/min and respiratory rate 250/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy subjets : normal respiratory function and no known lung disease
- lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis
- age >=18y
Key exclusion criteria (2 listed)
- increased pneumothorax risk under positive pressure ventilation
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency non-invasive ventilationAlso: HF-NIVComparison of 2 different settings of HF-NIV | Device | High - Low frequence sequence, Low - High frequence sequence |
Primary outcome
Duration of apnea
Time frame: 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
4 secondary outcomes
Transcutaneous carbon dioxide partial pressure
Time frame: 1 study session (2 hours)
Oxygen saturation of arterial blood
Time frame: 1 study session (2 hours)
Lung volume
Time frame: 1 study session (2 hours)
Subjective tolerance
Time frame: 1 study session (2 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alban Lovis, MD contact
Adam Ogna, MD contact
Alban Lovis principal investigator
Service de Pneumologie - CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency non-invasive ventilation in people with Non-invasive Ventilation and High-frequency Ventilation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alban Lovis, MD (alban.lovis@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of apnea (time frame: 1 study session (2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.