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TerminatedNCT02630784VNI VersusUpdated May 14, 2018

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

An interventional study of Non-Invasive Ventilation with Homecare ventilator and Non-Invasive Ventilation with ICU ventilator in Respiratory Acidosis in ICU Patients, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment

Why this study was terminated
lack of enrollement

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2015, registered Sep 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Respiratory Acidosis in ICU Patients

Keywords

  • Non-invasive ventilation
  • NIV ventilator
  • Exhalation by a calibrated leak
  • ICU ventilator
  • Respiratory acidosis
  • ICU
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.

Browse University Hospital, Grenoble studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureNon-Invasive Ventilation with Homecare ventilator
  • ProcedureNon-Invasive Ventilation with ICU ventilator
06

What researchers measure

Primary outcomes

  1. Carbon dioxide arterial pressure (PaCO2)

    Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation

    Time frame: After 2 hours of NIV

Secondary outcomes

  1. Arterial blood acidity (pH) after 2 hours of NIV

    Correction of arterial blood acidity (pH) after 2 hours of NIV

    Time frame: after 2 hours of NIV

  2. Transcutaneous PCO2

    Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.

    Time frame: 6 hours

  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

07

Study locations

1 site
  • CHU de Michallon
    Grenoble, 38000, France
08

References and documents

Publications

  • 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. PubMed 18635484 ↗
  • Carteaux 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. PubMed 22406958 ↗
  • Chiumello 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. PubMed 21424246 ↗
  • Ferrer 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. PubMed 19682735 ↗
  • Girault 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. PubMed 21680944 ↗
  • Janssens 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. PubMed 9515855 ↗
  • Peter 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. PubMed 16616558 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2015 to primary completion in May 2018, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2015
First posted
Dec 15, 2015
StartActual
May 27, 2015
Primary completionActual
May 5, 2018
CompletionActual
May 5, 2018
Last update
May 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02630784
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Dec 15, 2015
Start date
May 27, 2015
Primary completion
May 5, 2018
Completion
May 5, 2018
Last update
May 14, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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