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

Ventilated Patients Clinical Trial

— I-Nursing  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176329
• Other study ID #: MelunH-02
• Status: Completed
• Phase: N/A
• Start date: September 19, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: Hopital of Melun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Ill Patients
• Ventilated Patients

Intervention

Other:
• Nursing 1 : INTELLIVENT-ASV

• Nursing 2 : INTELLIVENT-ASV

• Nursing 1 : Conventional mode

• Nursing 2 : Conventional mode

Locations

Country	Name	City	State
France	Centre Hospitalier de Melun	Melun	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital of Melun

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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®) 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. — View 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®-ASV) in intensive care unit: a randomized trial. Minerva Anestesiol. 2016 Jun;82(6):657-68. Epub 2016 Mar 8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent with SpO2 values > 90 and < 95%	Pulse oxymetry monitoring	1 day
Secondary	Time spent with SpO2 values < or = 90%	Pulse oxymetry monitoring	1 day
Secondary	Time spent with SpO2 values > or = 95%	Pulse oxymetry monitoring	1 day