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
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
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
NCT ID
NCT04131660
First Posted
October 16, 2019
Last Updated
October 17, 2019
Sponsor
University Hospital, Rouen
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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