Clinical trial NCT03176329: Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients
Official title: Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Ill Patients
Ventilated Patients
Keywords: Full closed-loop ventilation control
Critical care
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective randomized crossover study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time spent with SpO2 values > 90 and < 95%
timeFrame: 1 day
Secondary outcomes:
measure: Time spent with SpO2 values < or = 90%
timeFrame: 1 day
measure: Time spent with SpO2 values > or = 95%
timeFrame: 1 day
Other outcomes:
Locations:
city: Melun
country: France
facility: Centre Hospitalier de Melun
state: Ile De France
Study officials:
affiliation: Mixed, ICU, Centre Hospitalier de Melun
name: Jonathan Chelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.