Acute Respiratory FailureVONIVOONCT04131660
Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
A study testing AVAPS-AE mode during NIV and S/T mode during NIV in people with Acute Respiratory Failure and Hypercapnic Respiratory Failure, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Hypercapnic Respiratory Failure, Respiratory Acidosis
- What is being tested?
- AVAPS-AE mode during NIV and S/T mode during NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2019to 30 Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of age
- Patient benefitting of social security
- Informed patient who signed the information note and the research enlighted consent form
- Admission in respiratory intensive care unit for an acid-hypercapnic exacerbation (defined by pH≤ 7,35)
- BMI ≥ 30kg/m2
- PaCO2 > 6.5 kPa on blood gases at ICU admission
Who cannot join
- Confirmed COPD with a spirometry (VEMS/CVF < 70%)
- Pregnant women, or breast-feeding women
- Patient with a judiciary or administrative liberty deprivation
- Patients under guardianship
- Contraindication to NIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Volume Targeted Pressure Support Ventilation vs. Pressure Support Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. This study focuses on patients at risk of obstructive apneas or obesity-hypoventilation syndrom (BMI≥30 kg/m²). Half of participants (33 patients) will receive non invasive ventilation with AVAPS-AE mode, the other half will receive non-invasive ventilation with S/T mode.
Read the detailed description
So far, in respiratory intensive care units, the usual treatment of patients with acute hypercapnic respiratory failure with acidosis is non-invasive ventilation set with a pressure support mode (S/T or VS/AI mode depending on the ventilator manufacturer).
AVAPS-AE mode is a volume targeted pressure support mode with an automatic PEP. With the forced oscillations method, the ventilator is able to detect the obstruction and the resistances of upper airways.
It allows the ventilator to change its pressure settings to keep the targeted volume and avoid apneas and hypoventilation.
That is why in patients with a BMI > 30 kg/m², at risk of obesity hypoventilation syndrom or obstructive apneas, this ventilation mode may be interesting.
AVAPS-AE has been evaluated in the home ventilation showing it is as efficient as S/T mode in controlling PaCO2.
However it has never been compared to S/T mode in acute respiratory failure care.
- Conditions
- Acute Respiratory Failure, Hypercapnic Respiratory Failure, Respiratory Acidosis, Obesity, Hypoventilation Syndrome, Apnea, Obstructive
- Being tested
- AVAPS-AE mode during NIV, S/T mode during NIV
- Keywords
- non-invasive ventilation, respiratory failure, obese, obesity, Hypoventilation Syndrome, apnea, hypercapnic, acidosis, AVAPS-AE, VONIVOO
- Medical subject headings
- Respiratory Insufficiency, Acidosis, Respiratory, Obesity, Sleep Apnea, Obstructive, Apnea, Hypercapnia, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVAPS-AE mode during NIVDevice
NIV will be setup in AVAPS-AE mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The range of positive expiratory pressure will be set between 4 and 14 cmH2O. The range of inspiratory pressure support will be set between 14 and 24 cmH2. The target tidal volume will be set to achieve 8 to 10 mL/kg of ideal body weight (Size (m) * Size (m) * 23).
S/T mode during NIVDevice
NIV will be setup in ST mode, with a Trilogy ventilation device (Respironics, Murrysville, PA).
The physician will decide the level of positive expiratory pressure and of pressure support.
| Study group | Role | What they receive |
|---|---|---|
| AVAPS-AE mode | Experimental | A volume targeted pressure support ventilation mode Receives: Device: AVAPS-AE mode during NIV |
| S/T mode | Active comparator | A pressure support ventilation mode Receives: Device: S/T mode during NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of hypercapnia
Time between admission and resolution of hypercapnia (≤ 6.5 kPa)
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Comparison of persistent apneic events on NIV (/h) during the first night
Comparison of persistent apneic events on NIV (/h) during the first night (determined with a respiratory polygraph) between S/T mode arm and AVAPS-AE mode arm (determined with an oxymeter)
Measured: through study completion, an average of 1 year
Comparison of patient-ventilator asynchronisms during NIV (/h)
Comparison of patient-ventilator asynchronisms during NIV (/h) between S/T mode arm and AVAPS-AE mode arm (determined with ventilator datas and a respiratory polygraph)
Measured: through study completion, an average of 1 year
Comparison of time during NIV with a oxygen saturation below 90%
Comparison of time during NIV with a oxygen saturation below 90% between S/T mode arm and AVAPS-AE mode arm (determined with an oxymeter)
Measured: through study completion, an average of 1 year
Comparison of NIV confort
Comparison of NIV confort between S/T mode arm and AVAPS-AE mode arm (NIV confort determined by a visual scale: 0: very comfortable to 10:not comfortable at all)
Measured: through study completion, an average of 1 year
Comparison of length of stay
Comparison of length of stay between S/T mode arm and AVAPS-AE mode arm
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start4 Dec 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Difficulty in enrolling new patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients are randomized in 2 arms at their admission : * S/T mode arm : the patient is ventilated as the standard procedure of the ICU, with settings defined by the pratician. * AVAPS-AE mode arm : the pratician sets NIV with a positive expiratory pressure set between 4 and 14 cmH2O, an inspiratory support between 14 and 24 cmH2O and a target tidal volume between 8 and 10 mL/kg of an ideal weight (Size (m) \* Size (m) \* 23).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Cuvelier, MD, PhD, Study director, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131660
- Sponsor's protocol ID
- 2018/409/HP
- Acronym
- VONIVOO
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be avaible by Email request to Dr. Patout Maxime
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Volume Targeted Pressure Support Ventilation vs. Pressure Support Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
- ClinicalTrials.gov ID
- NCT04131660
- Acronym / sponsor ID
- VONIVOO / 2018/409/HP
- Conditions
- Acute Respiratory Failure, Hypercapnic Respiratory Failure, Respiratory Acidosis, Obesity, Hypoventilation Syndrome, Apnea, Obstructive
- Keywords
- non-invasive ventilation, respiratory failure, obese, obesity, Hypoventilation Syndrome, apnea, hypercapnic, acidosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling new patients
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Oct 2019 (actual)
- 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.
This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. This study focuses on patients at risk of obstructive apneas or obesity-hypoventilation syndrom (BMI≥30 kg/m²). Half of participants (33 patients) will receive non invasive ventilation with AVAPS-AE mode, the other half will receive non-invasive ventilation with S/T mode.
Detailed description
So far, in respiratory intensive care units, the usual treatment of patients with acute hypercapnic respiratory failure with acidosis is non-invasive ventilation set with a pressure support mode (S/T or VS/AI mode depending on the ventilator manufacturer).
AVAPS-AE mode is a volume targeted pressure support mode with an automatic PEP. With the forced oscillations method, the ventilator is able to detect the obstruction and the resistances of upper airways.
It allows the ventilator to change its pressure settings to keep the targeted volume and avoid apneas and hypoventilation.
That is why in patients with a BMI > 30 kg/m², at risk of obesity hypoventilation syndrom or obstructive apneas, this ventilation mode may be interesting.
AVAPS-AE has been evaluated in the home ventilation showing it is as efficient as S/T mode in controlling PaCO2.
However it has never been compared to S/T mode in acute respiratory failure care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients are randomized in 2 arms at their admission : * S/T mode arm : the patient is ventilated as the standard procedure of the ICU, with settings defined by the pratician. * AVAPS-AE mode arm : the pratician sets NIV with a positive expiratory pressure set between 4 and 14 cmH2O, an inspiratory support between 14 and 24 cmH2O and a target tidal volume between 8 and 10 mL/kg of an ideal weight (Size (m) * Size (m) * 23).
| Arm | Type | Receives |
|---|---|---|
| AVAPS-AE mode | Experimental | Device: AVAPS-AE mode during NIVA volume targeted pressure support ventilation mode |
| S/T mode | Active comparator | Device: S/T mode during NIVA pressure support ventilation mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of age
- Patient benefitting of social security
- Informed patient who signed the information note and the research enlighted consent form
- Admission in respiratory intensive care unit for an acid-hypercapnic exacerbation (defined by pH≤ 7,35)
- BMI ≥ 30kg/m2
Key exclusion criteria (5 listed)
- Confirmed COPD with a spirometry (VEMS/CVF < 70%)
- Pregnant women, or breast-feeding women
- Patient with a judiciary or administrative liberty deprivation
- Patients under guardianship
- Contraindication to NIV
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 |
|---|---|---|
| AVAPS-AE mode during NIVNIV will be setup in AVAPS-AE mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The range of positive expiratory pressure will be set between 4 and 14 cmH2O. The range of inspiratory pressure support will be set between 14 and 24 cmH2. The target tidal volume will be set to achieve 8 to 10 mL/kg of ideal body weight (Size (m) * Size (m) * 23). | Device | AVAPS-AE mode |
| S/T mode during NIVNIV will be setup in ST mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The physician will decide the level of positive expiratory pressure and of pressure support. | Device | S/T mode |
Primary outcome
Resolution of hypercapnia
Time frame: through study completion, an average of 1 year
Time between admission and resolution of hypercapnia (≤ 6.5 kPa)
5 secondary outcomes
Comparison of persistent apneic events on NIV (/h) during the first night
Time frame: through study completion, an average of 1 year
Comparison of patient-ventilator asynchronisms during NIV (/h)
Time frame: through study completion, an average of 1 year
Comparison of time during NIV with a oxygen saturation below 90%
Time frame: through study completion, an average of 1 year
Comparison of NIV confort
Time frame: through study completion, an average of 1 year
Comparison of length of stay
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be avaible by Email request to Dr. Patout Maxime
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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.
Antoine Cuvelier, MD, PhD study director
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVAPS-AE mode during NIV and S/T mode during NIV in people with Acute Respiratory Failure and Hypercapnic Respiratory Failure, run by University Hospital, Rouen at 1 site in France.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Apr 2026. 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 France. 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?
The study was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of hypercapnia (time frame: through study completion, an average of 1 year). 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 15 Apr 2026.