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

Not Applicable

Terminated

• Conditions: Respiratory Acidosis in ICU Patients
• Interventions: Procedure: Non-Invasive Ventilation with Homecare ventilator; Procedure: Non-Invasive Ventilation with ICU ventilator

• Registration Number: NCT02630784
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Status Verified: 2018-05
• Primary Completion: 2018-05-05
• Study Completion: 2018-05-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Homecare ventilator	Non-Invasive Ventilation with Homecare ventilator	NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)
ICU ventilator	Non-Invasive Ventilation with ICU ventilator	NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.

Primary Outcome Measures

Name	Time	Method
Carbon dioxide arterial pressure (PaCO2)	After 2 hours of NIV	Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation

Secondary Outcome Measures

Name	Time	Method
Arterial blood acidity (pH) after 2 hours of NIV	after 2 hours of NIV	Correction of arterial blood acidity (pH) after 2 hours of NIV
Transcutaneous PCO2	6 hours	Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
Börg dyspnea scale	6 hours
RASS score	6 hours
Nurse satisfaction survey	6 hours
Patient satisfaction survey	6 hours

Trial Locations

Locations (1)

CHU de Michallon; 🇫🇷 Grenoble, France