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Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients

NCT03176329 — Not applicable, Completed, 267 participants, Hopital of Melun

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Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study

RegistryNCT03176329, acronym I-Nursing
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, supportive care
Enrollment267 (Actual)
SponsorHopital of Melun (Other)
ConditionsCritical Ill Patients, Ventilated Patients
InterventionsNursing 1 : INTELLIVENT-ASV, Nursing 2 : INTELLIVENT-ASV, Nursing 1 : Conventional mode, Nursing 2 : Conventional mode (Other)
Datesstart 2016-09-19, primary completion 2018-07-31, completion 2018-07-31, first posted 2017-06-05, last updated 2018-08-15
Locations1 site in France

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-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.

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
INTELLIVENT-ASV / Conventional modeOtherOther: 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-ASVOtherOther: 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.
  • Nursing 1 : INTELLIVENT-ASV (Other)
  • Nursing 2 : INTELLIVENT-ASV (Other)
  • Nursing 1 : Conventional mode (Other)
  • Nursing 2 : Conventional mode (Other)

+Outcome measures

Primary outcomes

  • Time spent with SpO2 values > 90 and < 95% [1 day]: Pulse oxymetry monitoring

Secondary outcomes

  • Time spent with SpO2 values < or = 90% [1 day]: Pulse oxymetry monitoring
  • Time spent with SpO2 values > or = 95% [1 day]: Pulse oxymetry monitoring

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Invasive mechanical ventilation for expected time >48h

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
Centre Hospitalier de MelunMelun, Île-de-France RegionFrance

+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. PMID 26957117
  • 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. PMID 24025234
  • 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. PMID 23619172
  • 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. PMID 22460854
  • Results publication: 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. PMID 32698860

+Investigators

My Notes