Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
NCT ID: NCT04131660
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2019-12-04
2021-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
* 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).
TREATMENT
SINGLE
Study Groups
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AVAPS-AE mode
A volume targeted pressure support ventilation mode
AVAPS-AE 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).
S/T mode
A pressure support ventilation mode
S/T mode during NIV
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.
Interventions
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AVAPS-AE 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).
S/T mode during NIV
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Pregnant women, or breast-feeding women
* Patient with a judiciary or administrative liberty deprivation
* Patients under guardianship
* Contraindication to NIV
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Antoine Cuvelier, MD, PhD
Role: STUDY_DIRECTOR
UH Rouen
Locations
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CHU Rouen
Rouen, , France
Countries
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Other Identifiers
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2018/409/HP
Identifier Type: -
Identifier Source: org_study_id
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