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

May 7, 2018 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CHU de Michallon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 2 hours of NIV

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 2 hours of NIV
Transcutaneous PCO2
Time Frame: 6 hours
Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
6 hours
Börg dyspnea scale
Time Frame: 6 hours
6 hours
RASS score
Time Frame: 6 hours
6 hours
Nurse satisfaction survey
Time Frame: 6 hours
6 hours
Patient satisfaction survey
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2015

Primary Completion (Actual)

May 5, 2018

Study Completion (Actual)

May 5, 2018

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00844-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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