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Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU (VNI Versus)

Primary Purpose

Respiratory Acidosis in ICU Patients

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non-Invasive Ventilation with Homecare ventilator
Non-Invasive Ventilation with ICU ventilator
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Acidosis in ICU Patients focused on measuring Non-invasive ventilation, NIV ventilator, Exhalation by a calibrated leak, ICU ventilator, Respiratory acidosis, ICU

Eligibility Criteria

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

Inclusion Criteria:

  • Dioxide carbon arterial pressure > 60 mmHg
  • Blood acidity (pH) <7.36

Exclusion Criteria:-Patient age under 18

  • Pregnant woman
  • Cognitive disorder (other than the one induced by hypercapnia)
  • Acute intoxication with morphine or benzodiazepines
  • Patient already equipped prior to admission with a home NIV or Continuous Positive Airway Pressure (CPAP) device
  • All contraindications to NIV already described in the French Consensus Conference on NIV, from 2006.

Sites / Locations

  • CHU de Michallon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Homecare ventilator

ICU ventilator

Arm Description

NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)

NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.

Outcomes

Primary Outcome Measures

Carbon dioxide arterial pressure (PaCO2)
Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation

Secondary Outcome Measures

Arterial blood acidity (pH) after 2 hours of NIV
Correction of arterial blood acidity (pH) after 2 hours of NIV
Transcutaneous PCO2
Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
Börg dyspnea scale
RASS score
Nurse satisfaction survey
Patient satisfaction survey

Full Information

First Posted
September 10, 2015
Last Updated
May 7, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02630784
Brief Title
Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU
Acronym
VNI Versus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollement
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
May 5, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis. This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve. Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours. Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Acidosis in ICU Patients
Keywords
Non-invasive ventilation, NIV ventilator, Exhalation by a calibrated leak, ICU ventilator, Respiratory acidosis, ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Homecare ventilator
Arm Type
Experimental
Arm Description
NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)
Arm Title
ICU ventilator
Arm Type
Active Comparator
Arm Description
NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.
Intervention Type
Procedure
Intervention Name(s)
Non-Invasive Ventilation with Homecare ventilator
Intervention Type
Procedure
Intervention Name(s)
Non-Invasive Ventilation with ICU ventilator
Primary Outcome Measure Information:
Title
Carbon dioxide arterial pressure (PaCO2)
Description
Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation
Time Frame
After 2 hours of NIV
Secondary Outcome Measure Information:
Title
Arterial blood acidity (pH) after 2 hours of NIV
Description
Correction of arterial blood acidity (pH) after 2 hours of NIV
Time Frame
after 2 hours of NIV
Title
Transcutaneous PCO2
Description
Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
Time Frame
6 hours
Title
Börg dyspnea scale
Time Frame
6 hours
Title
RASS score
Time Frame
6 hours
Title
Nurse satisfaction survey
Time Frame
6 hours
Title
Patient satisfaction survey
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dioxide carbon arterial pressure > 60 mmHg Blood acidity (pH) <7.36 Exclusion Criteria:-Patient age under 18 Pregnant woman Cognitive disorder (other than the one induced by hypercapnia) Acute intoxication with morphine or benzodiazepines Patient already equipped prior to admission with a home NIV or Continuous Positive Airway Pressure (CPAP) device All contraindications to NIV already described in the French Consensus Conference on NIV, from 2006.
Facility Information:
Facility Name
CHU de Michallon
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18635484
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
19682735
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Janssens JP, Howarth-Frey C, Chevrolet JC, Abajo B, Rochat T. Transcutaneous PCO2 to monitor noninvasive mechanical ventilation in adults: assessment of a new transcutaneous PCO2 device. Chest. 1998 Mar;113(3):768-73. doi: 10.1378/chest.113.3.768.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU

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