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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Critical Ill Patients Ventilated Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective randomized crossover study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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INTELLIVENT-ASV / Conventional mode

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

Group Type OTHER

Nursing 1 : INTELLIVENT-ASV

Intervention Type OTHER

Nursing 2 : Conventional mode

Intervention Type OTHER

Conventional mode / INTELLIVENT-ASV

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.

Group Type OTHER

Nursing 2 : INTELLIVENT-ASV

Intervention Type OTHER

Nursing 1 : Conventional mode

Intervention Type OTHER

Interventions

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Nursing 1 : INTELLIVENT-ASV

Intervention Type OTHER

Nursing 2 : INTELLIVENT-ASV

Intervention Type OTHER

Nursing 1 : Conventional mode

Intervention Type OTHER

Nursing 2 : Conventional mode

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No