Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients (I-Nursing)

Hopital of Melun

Status: Completed

Conditions: Ventilated Patients; Critical Ill Patients

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03176329

MelunH-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

INTELLIVENT-ASV / Conventional mode

Other group

Description:

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

Treatment:

Other: Nursing 1 : INTELLIVENT-ASV

Other: Nursing 2 : Conventional mode

Conventional mode / INTELLIVENT-ASV

Other group

Description:

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.

Treatment:

Other: Nursing 1 : Conventional mode

Other: Nursing 2 : INTELLIVENT-ASV