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Trial record 46 of 670 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT02630784
Recruitment Status : Terminated (lack of enrollement)
First Posted : December 15, 2015
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Respiratory Acidosis in ICU Patients Procedure: Non-Invasive Ventilation with Homecare ventilator Procedure: Non-Invasive Ventilation with ICU ventilator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : May 27, 2015
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : May 5, 2018

Arm Intervention/treatment
Experimental: Homecare ventilator
NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)
Procedure: Non-Invasive Ventilation with Homecare ventilator
Active Comparator: ICU ventilator
NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.
Procedure: Non-Invasive Ventilation with ICU ventilator



Primary Outcome Measures :
  1. Carbon dioxide arterial pressure (PaCO2) [ Time Frame: After 2 hours of NIV ]
    Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation


Secondary Outcome Measures :
  1. Arterial blood acidity (pH) after 2 hours of NIV [ Time Frame: after 2 hours of NIV ]
    Correction of arterial blood acidity (pH) after 2 hours of NIV

  2. Transcutaneous PCO2 [ Time Frame: 6 hours ]
    Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.

  3. Börg dyspnea scale [ Time Frame: 6 hours ]
  4. RASS score [ Time Frame: 6 hours ]
  5. Nurse satisfaction survey [ Time Frame: 6 hours ]
  6. Patient satisfaction survey [ Time Frame: 6 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630784


Locations
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France
CHU de Michallon
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02630784     History of Changes
Other Study ID Numbers: 2014-A00844-43
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Keywords provided by University Hospital, Grenoble:
Non-invasive ventilation
NIV ventilator
Exhalation by a calibrated leak
ICU ventilator
Respiratory acidosis
ICU
Additional relevant MeSH terms:
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Acidosis, Respiratory
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases