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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nursing 1 : INTELLIVENT-ASV | Other |
| ||
| Nursing 2 : INTELLIVENT-ASV |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent with SpO2 values > 90 and < 95% | Pulse oxymetry monitoring | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent with SpO2 values < or = 90% | Pulse oxymetry monitoring | 1 day |
| Time spent with SpO2 values > or = 95% | Pulse oxymetry monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Chelly, MD | Mixed, ICU, Centre Hospitalier de Melun | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Melun | Melun | ÃŽle-de-France Region | 77000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26957117 | Background | 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. | |
| 24025234 | Background | Arnal 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. |
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Prospective randomized crossover study
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| Other |
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| Nursing 1 : Conventional mode | Other |
|
| Nursing 2 : Conventional mode | Other |
|
| 1 day |
| 23619172 | Background | Clavieras 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. |
| 22460854 | Background | Arnal 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. |
| 32698860 | Derived | Chelly 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. |