Study Stopped
lack of enrollement
Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU
VNI Versus
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2015
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2018
CompletedMay 14, 2018
May 1, 2018
2.9 years
September 10, 2015
May 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carbon dioxide arterial pressure (PaCO2)
Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation
After 2 hours of NIV
Secondary Outcomes (6)
Arterial blood acidity (pH) after 2 hours of NIV
after 2 hours of NIV
Transcutaneous PCO2
6 hours
Börg dyspnea scale
6 hours
RASS score
6 hours
Nurse satisfaction survey
6 hours
- +1 more secondary outcomes
Study Arms (2)
Homecare ventilator
EXPERIMENTALNIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)
ICU ventilator
ACTIVE COMPARATORNIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.
Interventions
Eligibility Criteria
You may qualify if:
- Dioxide carbon arterial pressure \> 60 mmHg
- Blood acidity (pH) \<7.36
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Michallon
Grenoble, 38000, France
Related Publications (7)
Akada S, Takeda S, Yoshida Y, Nakazato K, Mori M, Hongo T, Tanaka K, Sakamoto A. The efficacy of dexmedetomidine in patients with noninvasive ventilation: a preliminary study. Anesth Analg. 2008 Jul;107(1):167-70. doi: 10.1213/ane.0b013e3181732dc2.
PMID: 18635484BACKGROUNDCarteaux G, Lyazidi A, Cordoba-Izquierdo A, Vignaux L, Jolliet P, Thille AW, Richard JM, Brochard L. Patient-ventilator asynchrony during noninvasive ventilation: a bench and clinical study. Chest. 2012 Aug;142(2):367-376. doi: 10.1378/chest.11-2279.
PMID: 22406958BACKGROUNDChiumello D, Chevallard G, Gregoretti C. Non-invasive ventilation in postoperative patients: a systematic review. Intensive Care Med. 2011 Jun;37(6):918-29. doi: 10.1007/s00134-011-2210-8. Epub 2011 Mar 18.
PMID: 21424246BACKGROUNDFerrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
PMID: 19682735BACKGROUNDGirault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guerin C, Guiot P, Benichou J, Bonmarchand G; VENISE Trial Group. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med. 2011 Sep 15;184(6):672-9. doi: 10.1164/rccm.201101-0035OC.
PMID: 21680944BACKGROUNDJanssens 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.
PMID: 9515855BACKGROUNDPeter JV, Moran JL, Phillips-Hughes J, Graham P, Bersten AD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet. 2006 Apr 8;367(9517):1155-63. doi: 10.1016/S0140-6736(06)68506-1.
PMID: 16616558BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
December 15, 2015
Study Start
May 27, 2015
Primary Completion
May 5, 2018
Study Completion
May 5, 2018
Last Updated
May 14, 2018
Record last verified: 2018-05