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

NCT02630784 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-05-14

No results posted yet for this study

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.

Conditions

  • Respiratory Acidosis in ICU Patients

Interventions

PROCEDURE

Non-Invasive Ventilation with Homecare ventilator

PROCEDURE

Non-Invasive Ventilation with ICU ventilator

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-27
Primary Completion
2018-05-05
Completion
2018-05-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630784 on ClinicalTrials.gov