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

NCT04131660 | Terminated

• 1 other identifier: 2018/409/HP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

non-invasive ventilation; respiratory failure; obese; obesity; Hypoventilation Syndrome; apnea; hypercapnic; acidosis; AVAPS-AE; VONIVOO

Outcome Measures

Primary Outcomes (1)

• Resolution of hypercapnia

  Time between admission and resolution of hypercapnia (≤ 6.5 kPa)

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Comparison of persistent apneic events on NIV (/h) during the first night

  through study completion, an average of 1 year

• Comparison of patient-ventilator asynchronisms during NIV (/h)

  through study completion, an average of 1 year

• Comparison of time during NIV with a oxygen saturation below 90%

  through study completion, an average of 1 year

• Comparison of NIV confort

  through study completion, an average of 1 year

• Comparison of length of stay

  through study completion, an average of 1 year

Study Arms (2)

AVAPS-AE mode

EXPERIMENTAL

A volume targeted pressure support ventilation mode

Device: AVAPS-AE mode during NIV

S/T mode

ACTIVE COMPARATOR

A pressure support ventilation mode

Device: S/T mode during NIV

Interventions

AVAPS-AE mode during NIV DEVICE

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).

AVAPS-AE mode

S/T mode during NIV DEVICE

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.

S/T mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Acidosis, Respiratory; Obesity; Sleep Apnea, Obstructive; Apnea; Hypercapnia; Acidosis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory

Study Officials

• Antoine Cuvelier, MD, PhD

  UH Rouen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The ventilator used in both arms will be similar in appareance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: December 4, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 2 years of study publication
• Access Criteria: Researchers in the field of acute/chronic respiratory failure.

Locations

FR (1)