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

Primary Purpose

Acute Respiratory Failure, Hypercapnic Respiratory Failure, Respiratory Acidosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AVAPS-AE mode during NIV
S/T mode during NIV
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring non-invasive ventilation, respiratory failure, obese, obesity, Hypoventilation Syndrome, apnea, hypercapnic, acidosis, AVAPS-AE, VONIVOO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AVAPS-AE mode

    S/T mode

    Arm Description

    A volume targeted pressure support ventilation mode

    A pressure support ventilation mode

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Comparison of persistent apneic events on NIV (/h) during the first night
    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 patient-ventilator asynchronisms during NIV (/h)
    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 time during NIV with a oxygen saturation below 90%
    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
    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 length of stay
    Comparison of length of stay between S/T mode arm and AVAPS-AE mode arm

    Full Information

    First Posted
    October 16, 2019
    Last Updated
    October 17, 2019
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04131660
    Brief Title
    Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
    Acronym
    VONIVOO
    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

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 30, 2019 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    Participant
    Masking Description
    The ventilator used in both arms will be similar in appareance.
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AVAPS-AE mode
    Arm Type
    Experimental
    Arm Description
    A volume targeted pressure support ventilation mode
    Arm Title
    S/T mode
    Arm Type
    Active Comparator
    Arm Description
    A pressure support ventilation mode
    Intervention Type
    Device
    Intervention Name(s)
    AVAPS-AE mode during NIV
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    S/T mode during NIV
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Resolution of hypercapnia
    Description
    Time between admission and resolution of hypercapnia (≤ 6.5 kPa)
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Comparison of persistent apneic events on NIV (/h) during the first night
    Description
    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)
    Time Frame
    through study completion, an average of 1 year
    Title
    Comparison of patient-ventilator asynchronisms during NIV (/h)
    Description
    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)
    Time Frame
    through study completion, an average of 1 year
    Title
    Comparison of time during NIV with a oxygen saturation below 90%
    Description
    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)
    Time Frame
    through study completion, an average of 1 year
    Title
    Comparison of NIV confort
    Description
    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)
    Time Frame
    through study completion, an average of 1 year
    Title
    Comparison of length of stay
    Description
    Comparison of length of stay between S/T mode arm and AVAPS-AE mode arm
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maxime Patout, MD
    Phone
    0033232889083
    Ext
    40014
    Email
    maxime.patout@chu-rouen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christian Caillard, MD
    Phone
    0033663759875
    Email
    maxime.patout@chu-rouen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antoine Cuvelier, MD, PhD
    Organizational Affiliation
    UH Rouen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be avaible by Email request to Dr. Patout Maxime
    IPD Sharing Time Frame
    Within 2 years of study publication
    IPD Sharing Access Criteria
    Researchers in the field of acute/chronic respiratory failure.

    Learn more about this trial

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

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