Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation (VONIVOO)

University Hospital, Rouen

Status: Unknown

Conditions: Hypercapnic Respiratory Failure; Hypoventilation Syndrome; Obesity; Apnea, Obstructive; Acute Respiratory Failure; Respiratory Acidosis

Treatments: Device: AVAPS-AE mode during NIV; Device: S/T mode during NIV

Study type: Interventional

Funder types: Other

Identifiers

NCT04131660

2018/409/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

AVAPS-AE mode

Experimental group

Description:

A volume targeted pressure support ventilation mode

Treatment:

Device: AVAPS-AE mode during NIV

S/T mode

Active Comparator group

Description:

A pressure support ventilation mode

Treatment:

Device: S/T mode during NIV