Critical Ill PatientsI-NursingNCT03176329
Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients
A study testing Nursing 1 : INTELLIVENT-ASV, Nursing 2 : INTELLIVENT-ASV and Nursing 1 : Conventional mode in people with Critical Ill Patients and Ventilated Patients, run by Hopital of Melun at 1 site in France.
Trial summary
Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Ill Patients, Ventilated Patients
- What is being tested?
- Nursing 1 : INTELLIVENT-ASV, Nursing 2 : INTELLIVENT-ASV and Nursing 1 : Conventional mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2016to 31 Jul 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
- Invasive mechanical ventilation for expected time >48h
Who cannot join
- Pregnancy
- Neuromuscular blocking agent (discontinuous or continuous) infusion
- Inspired oxygen fraction (FiO2) setting > or = 60%
- Mobilization contraindication (hemodynamic instability, unstable vertebral trauma, etc.)
- Neurological breathing (patients with brain injury)
- Pulse oxymetry monitoring unavailable
- Expected ventilation weaning <24h after randomization.
- Moribund patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study
Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.
The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.
Read the detailed description
Prospective randomized cross over study including all consecutive ventilated patient with predicted duration of ventilation > 48 hours, inspired oxygen fraction < 60% and without neuromuscular blocking agent.
Patient were randomized to be ventilated with full closed-loop control or conventional ventilation 30 minutes before the first nursing period after inclusion. The ventilator was switched in the other mode (conventional or full closed-loop respectively), 30 minutes before the following nursing period. Between this two consecutive nursing periods, ventilation mode is choosed by the attending physician.
The primary outcome was the oxygenation measured by pulse oxymetry during the nursing periods.
- Conditions
- Critical Ill Patients, Ventilated Patients
- Being tested
- Nursing 1 : INTELLIVENT-ASV, Nursing 2 : INTELLIVENT-ASV, Nursing 1 : Conventional mode, Nursing 2 : Conventional mode
- Keywords
- Full closed-loop ventilation control, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing 1 : INTELLIVENT-ASVOther
Nursing 2 : INTELLIVENT-ASVOther
Nursing 1 : Conventional modeOther
Nursing 2 : Conventional modeOther
| Study group | Role | What they receive |
|---|---|---|
| INTELLIVENT-ASV / Conventional mode | Other | Full closed-loop ventilation control (INTELLIVENT-ASV) is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to conventional ventilation 30 minutes before Nursing 2 Receives: Other: Nursing 1 : INTELLIVENT-ASV; Other: Nursing 2 : Conventional mode |
| Conventional mode / INTELLIVENT-ASV | Other | Conventional ventilation control is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to full closed-loop ventilation (INTELLIVENT-ASV) 30 minutes before Nursing 2. Receives: Other: Nursing 2 : INTELLIVENT-ASV; Other: Nursing 1 : Conventional mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with SpO2 values > 90 and < 95%
Pulse oxymetry monitoring
Measured: 1 day
Secondary outcomes (2)
Time spent with SpO2 values < or = 90%
Pulse oxymetry monitoring
Measured: 1 day
Time spent with SpO2 values > or = 95%
Pulse oxymetry monitoring
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start19 Sep 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critical Ill PatientsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized crossover study
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital of Melun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelly Jonathan, Hopital of Melun
- Investigators
- Jonathan Chelly, MD, Principal investigator, Mixed, ICU, Centre Hospitalier de Melun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176329
- Sponsor's protocol ID
- MelunH-02
- Acronym
- I-Nursing
- Status last verified
- Aug 2018
- First submitted
- 28 May 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bialais E, Wittebole X, Vignaux L, Roeseler J, Wysocki M, Meyer J, Reychler G, Novotni D, Sottiaux T, Laterre PF, Hantson P. Closed-loop ventilation mode (IntelliVent(R)-ASV) in intensive care unit: a randomized trial. Minerva Anestesiol. 2016 Jun;82(6):657-68. Epub 2016 Mar 8.
PubMed 26957117Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.
PubMed 24025234Clavieras N, Wysocki M, Coisel Y, Galia F, Conseil M, Chanques G, Jung B, Arnal JM, Matecki S, Molinari N, Jaber S. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation. Anesthesiology. 2013 Sep;119(3):631-41. doi: 10.1097/ALN.0b013e3182952608.
PubMed 23619172Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.
PubMed 22460854Chelly J, Mazerand S, Jochmans S, Weyer CM, Pourcine F, Ellrodt O, Thieulot-Rolin N, Serbource-Goguel J, Sy O, Vong LVP, Monchi M. Automated vs. conventional ventilation in the ICU: a randomized controlled crossover trial comparing blood oxygen saturation during daily nursing procedures (I-NURSING). Crit Care. 2020 Jul 22;24(1):453. doi: 10.1186/s13054-020-03155-3.
PubMed 32698860
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT03176329
- Acronym / sponsor ID
- I-Nursing / MelunH-02
- Conditions
- Critical Ill Patients, Ventilated Patients
- Keywords
- Full closed-loop ventilation control, Critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Hopital of MelunUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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.
Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.
The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.
Detailed description
Prospective randomized cross over study including all consecutive ventilated patient with predicted duration of ventilation > 48 hours, inspired oxygen fraction < 60% and without neuromuscular blocking agent.
Patient were randomized to be ventilated with full closed-loop control or conventional ventilation 30 minutes before the first nursing period after inclusion. The ventilator was switched in the other mode (conventional or full closed-loop respectively), 30 minutes before the following nursing period. Between this two consecutive nursing periods, ventilation mode is choosed by the attending physician.
The primary outcome was the oxygenation measured by pulse oxymetry during the nursing periods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| INTELLIVENT-ASV / Conventional mode | Other | Other: Nursing 1 : INTELLIVENT-ASV, Other: Nursing 2 : Conventional modeFull closed-loop ventilation control (INTELLIVENT-ASV) is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to conventional ventilation 30 minutes before Nursing 2 |
| Conventional mode / INTELLIVENT-ASV | Other | Other: Nursing 2 : INTELLIVENT-ASV, Other: Nursing 1 : Conventional modeConventional ventilation control is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to full closed-loop ventilation (INTELLIVENT-ASV) 30 minutes before Nursing 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invasive mechanical ventilation for expected time >48h
Key exclusion criteria (8 listed)
- Pregnancy
- Neuromuscular blocking agent (discontinuous or continuous) infusion
- Inspired oxygen fraction (FiO2) setting > or = 60%
- Mobilization contraindication (hemodynamic instability, unstable vertebral trauma, etc.)
- Neurological breathing (patients with brain injury)
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 |
|---|---|---|
| Nursing 1 : INTELLIVENT-ASV | Other | INTELLIVENT-ASV / Conventional mode |
| Nursing 2 : INTELLIVENT-ASV | Other | Conventional mode / INTELLIVENT-ASV |
| Nursing 1 : Conventional mode | Other | Conventional mode / INTELLIVENT-ASV |
| Nursing 2 : Conventional mode | Other | INTELLIVENT-ASV / Conventional mode |
Primary outcome
Time spent with SpO2 values > 90 and < 95%
Time frame: 1 day
Pulse oxymetry monitoring
2 secondary outcomes
Time spent with SpO2 values < or = 90%
Time frame: 1 day
Time spent with SpO2 values > or = 95%
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Background: PubMed 26957117Bialais E, Wittebole X, Vignaux L, Roeseler J, Wysocki M, Meyer J, Reychler G, Novotni D, Sottiaux T, Laterre PF, Hantson P. Closed-loop ventilation mode (IntelliVent(R)-ASV) in intensive care unit: a randomized trial. Minerva Anestesiol. 2016 Jun;82(6):657-68. Epub 2016 Mar 8.
- Background: PubMed 24025234Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.
- Background: PubMed 23619172Clavieras N, Wysocki M, Coisel Y, Galia F, Conseil M, Chanques G, Jung B, Arnal JM, Matecki S, Molinari N, Jaber S. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation. Anesthesiology. 2013 Sep;119(3):631-41. doi: 10.1097/ALN.0b013e3182952608.
- Background: PubMed 22460854Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.
- Derived from this study: PubMed 32698860Chelly J, Mazerand S, Jochmans S, Weyer CM, Pourcine F, Ellrodt O, Thieulot-Rolin N, Serbource-Goguel J, Sy O, Vong LVP, Monchi M. Automated vs. conventional ventilation in the ICU: a randomized controlled crossover trial comparing blood oxygen saturation during daily nursing procedures (I-NURSING). Crit Care. 2020 Jul 22;24(1):453. doi: 10.1186/s13054-020-03155-3.
- Individual participant dataSharing planned: No
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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.
Jonathan Chelly, MD principal investigator
Mixed, ICU, Centre Hospitalier de Melun
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing 1 : INTELLIVENT-ASV, Nursing 2 : INTELLIVENT-ASV and Nursing 1 : Conventional mode in people with Critical Ill Patients and Ventilated Patients, run by Hopital of Melun 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 15 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time spent with SpO2 values > 90 and < 95% (time frame: 1 day). 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 NCT03176329, which also lists 5 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 15 Aug 2018.