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

Not Applicable

• Conditions: Hypercapnic Respiratory Failure; Acute Respiratory Failure; Respiratory Acidosis; Apnea, Obstructive; Obesity; Hypoventilation Syndrome
• Interventions: Device: AVAPS-AE mode during NIV; Device: S/T mode during NIV

• Registration Number: NCT04131660
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-17
• Study First Posted: 2019-10-18
• Last Update Posted: 2019-10-18
• Study Start: 2019-11-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVAPS-AE mode	AVAPS-AE mode during NIV	A volume targeted pressure support ventilation mode
S/T mode	S/T mode during NIV	A pressure support ventilation mode

Primary Outcome Measures

Name	Time	Method
Resolution of hypercapnia	through study completion, an average of 1 year	Time between admission and resolution of hypercapnia (≤ 6.5 kPa)

Secondary Outcome Measures

Name	Time	Method
Comparison of persistent apneic events on NIV (/h) during the first night	through study completion, an average of 1 year	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)
Comparison of time during NIV with a oxygen saturation below 90%	through study completion, an average of 1 year	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)
Comparison of NIV confort	through study completion, an average of 1 year	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)
Comparison of patient-ventilator asynchronisms during NIV (/h)	through study completion, an average of 1 year	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)
Comparison of length of stay	through study completion, an average of 1 year	Comparison of length of stay between S/T mode arm and AVAPS-AE mode arm