Clinical trial NCT04131660: Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
AVAPS-AE
VONIVOO
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Resolution of hypercapnia
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Comparison of persistent apneic events on NIV (/h) during the first night
timeFrame: through study completion, an average of 1 year
measure: Comparison of patient-ventilator asynchronisms during NIV (/h)
timeFrame: through study completion, an average of 1 year
measure: Comparison of time during NIV with a oxygen saturation below 90%
timeFrame: through study completion, an average of 1 year
measure: Comparison of NIV confort
timeFrame: through study completion, an average of 1 year
measure: Comparison of length of stay
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: UH Rouen
name: Antoine Cuvelier, MD, PhD
role: STUDY_DIRECTOR
References: