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

Study Overview
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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.

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.

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

Conditions
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Critical Ill Patients, Ventilated Patients

Intervention / Treatment
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* Other: Nursing 1 : INTELLIVENT-ASV
* Other: Nursing 2 : INTELLIVENT-ASV
* Other: Nursing 1 : Conventional mode
* Other: Nursing 2 : Conventional mode


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective randomized crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: INTELLIVENT-ASV / Conventional mode<br>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<br> <br> Other: Nursing 2 : Conventional mode<br> <br> |
| Other: Conventional mode / INTELLIVENT-ASV<br>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<br> <br> Other: Nursing 1 : Conventional mode<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent with SpO2 values > 90 and < 95% | Pulse oxymetry monitoring | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent with SpO2 values < or = 90% | Pulse oxymetry monitoring | 1 day | 
| Time spent with SpO2 values > or = 95% | Pulse oxymetry monitoring | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Full closed-loop ventilation control, Critical care