An interventional study of AVAPS-AE mode during NIV and S/T mode during NIV in Acute Respiratory Failure, Hypercapnic Respiratory Failure and Respiratory Acidosis, sponsored by University Hospital, Rouen. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Acidosis, Respiratory; 6 are open to participants now.
This study's enrollment of 14 is below the median of 18 across 16 interventional studies indexed under Acidosis, Respiratory.
Browse Acidosis, Respiratory studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
Compared within Acidosis, Respiratory, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Insufficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A volume targeted pressure support ventilation mode
Device: AVAPS-AE mode during NIV
A pressure support ventilation mode
Device: S/T mode during NIV
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).
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.
Resolution of hypercapnia
Time between admission and resolution of hypercapnia (≤ 6.5 kPa)
Time frame: through study completion, an average of 1 year
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: through study completion, an average of 1 year
Plan to share: Yes — Data will be avaible by Email request to Dr. Patout Maxime
Supporting information: Study protocol, Informed consent form
Time frame: Within 2 years of study publication
Access criteria: Researchers in the field of acute/chronic respiratory failure.
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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