Respiratory Acidosis in ICU PatientsVNI VersusNCT02630784
Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU
A study testing Non-Invasive Ventilation with Homecare ventilator and Non-Invasive Ventilation with ICU ventilator in people with Respiratory Acidosis in ICU Patients, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Acidosis in ICU Patients
- What is being tested?
- Non-Invasive Ventilation with Homecare ventilator and Non-Invasive Ventilation with ICU ventilator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2015to 5 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dioxide carbon arterial pressure > 60 mmHg
- Blood acidity (pH) <7.36
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Non-Invasive Ventilation with Homecare ventilator, Non-Invasive Ventilation with ICU ventilator
- Keywords
- Non-invasive ventilation, NIV ventilator, Exhalation by a calibrated leak, ICU ventilator, Respiratory acidosis, ICU
- Medical subject headings
- Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Ventilation with Homecare ventilatorProcedure or surgery
Non-Invasive Ventilation with ICU ventilatorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Homecare ventilator | Experimental | NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak) Receives: Procedure: Non-Invasive Ventilation with Homecare ventilator |
| ICU ventilator | Active comparator | NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve. Receives: Procedure: Non-Invasive Ventilation with ICU ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon dioxide arterial pressure (PaCO2)
Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation
Measured: After 2 hours of NIV
Secondary outcomes (6)
Arterial blood acidity (pH) after 2 hours of NIV
Correction of arterial blood acidity (pH) after 2 hours of NIV
Measured: after 2 hours of NIV
Transcutaneous PCO2
Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
Measured: 6 hours
Börg dyspnea scale
Measured: 6 hours
RASS score
Measured: 6 hours
Nurse satisfaction survey
Measured: 6 hours
Patient satisfaction survey
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start27 May 2015
- Primary completion5 May 2018
- Study completion5 May 2018
Why it stopped: lack of enrollement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory Acidosis in ICU PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630784
- Sponsor's protocol ID
- 2014-A00844-43
- Acronym
- VNI Versus
- Status last verified
- May 2018
- First submitted
- 10 Sep 2015
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
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 18635484Carteaux 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 22406958Chiumello 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 21424246Ferrer 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 19682735Girault 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 21680944Janssens 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 9515855Peter 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU
- ClinicalTrials.gov ID
- NCT02630784
- Acronym / sponsor ID
- VNI Versus / 2014-A00844-43
- Conditions
- Respiratory Acidosis in ICU Patients
- Keywords
- Non-invasive ventilation, NIV ventilator, Exhalation by a calibrated leak, ICU ventilator, Respiratory acidosis, ICU
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollement
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homecare ventilator | Experimental | Procedure: Non-Invasive Ventilation with Homecare ventilatorNIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak) |
| ICU ventilator | Active comparator | Procedure: Non-Invasive Ventilation with ICU ventilatorNIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dioxide carbon arterial pressure > 60 mmHg
- Blood acidity (pH) <7.36
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Ventilation with Homecare ventilator | Procedure or surgery | Homecare ventilator |
| Non-Invasive Ventilation with ICU ventilator | Procedure or surgery | ICU ventilator |
Primary outcome
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
6 secondary outcomes
Arterial blood acidity (pH) after 2 hours of NIV
Time frame: after 2 hours of NIV
Transcutaneous PCO2
Time frame: 6 hours
Börg dyspnea scale
Time frame: 6 hours
RASS score
Time frame: 6 hours
Nurse satisfaction survey
Time frame: 6 hours
Patient satisfaction survey
Time frame: 6 hours
Results and safety
The study was stopped early (reason given: lack of enrollement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Background: PubMed 18635484Akada 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.
- Background: PubMed 22406958Carteaux 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.
- Background: PubMed 21424246Chiumello 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.
- Background: PubMed 19682735Ferrer 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.
- Background: PubMed 21680944Girault 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.
- Background: PubMed 9515855Janssens 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.
- Background: PubMed 16616558Peter 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.
Related trials for Respiratory Acidosis in ICU Patients
RecruitingObservational study
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Ventilation with Homecare ventilator and Non-Invasive Ventilation with ICU ventilator in people with Respiratory Acidosis in ICU Patients, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of enrollement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon dioxide arterial pressure (PaCO2) (time frame: After 2 hours of NIV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630784, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.