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

NCT03176329 | Completed

• 1 other identifier: MelunH-02
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Ill Patients; Ventilated Patients

Keywords

Full closed-loop ventilation control; Critical care

Outcome Measures

Primary Outcomes (1)

• Time spent with SpO2 values > 90 and < 95%

  Pulse oxymetry monitoring

  1 day

Secondary Outcomes (2)

• Time spent with SpO2 values < or = 90%

  1 day

• Time spent with SpO2 values > or = 95%

  1 day

Study Arms (2)

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

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.

Other: Nursing 2 : INTELLIVENT-ASV; Other: Nursing 1 : Conventional mode

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive mechanical ventilation for expected time \>48h

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital of Melun: lead

Study Sites (1)

Centre Hospitalier de Melun

Melun, Île-de-France Region, 77000, France

Location

Related Publications (5)

• 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 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.

  PMID: 24025234 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.

  PMID: 23619172 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.

  PMID: 22460854 BACKGROUND

• 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 DERIVED

Study Officials

• Jonathan Chelly, MD

  Mixed, ICU, Centre Hospitalier de Melun

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective randomized crossover study

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 5, 2017
• Study Start: September 19, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)