NCT04131660

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure
• Hypercapnic Respiratory Failure
• Respiratory Acidosis
• Obesity
• Hypoventilation Syndrome
• Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	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).
DEVICE	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.

Timeline

• Start date: 2019-12-04
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2019-10-18
• Last updated: 2026-04-15

Locations

1 site across 1 country: France