SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

Study Overview
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Brief Summary
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Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians. Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality. NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment. A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction. The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.

Official Title
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Clinical Evaluation of an Automated Knowledge-based Computer Driven System (SmartCare/PS-NIV) Designed to Automatically Adapt Pressure Support Level and Expiratory Cycling During Non Invasive Ventilation, a Feasability Study.

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute respiratory failure requiring non invasive ventilation ICU patient equipped with an arterial line. Exclusion Criteria: Contra-indications to NIV: impaired consciousness absence of patient cooperation severe hemodynamic instability vomiting facial lesions indication for immediate intubation Acute neurological problem Poor short term prognosis

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br> | Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure. | The main aim of the study is to explore the feasibility of using the Smartcare-NIV system to deliver non-invasive ventilation (NIV) in case of acute respiratory failure. Practically, we will describe how the NIV tratment will go on when using the Smartcare system and report how the system automatically adapt the ventilator settings. | 45 minute NIV-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate |  | 45 minutes | 
| Minute ventilation |  | 45 minutes | 
| Tidal volumes |  | 45 minutes | 
| Leaks |  | 45 minutes | 
| O2 saturation | Transcutaneous measurement | 45 minutes | 
| Alarms generated by the ventilator |  | 45 minutes | 
| Manual ventilator settings modifications required |  | 45 minutes | 
| Patient-ventilator asynchronies |  | 45 minutes | 
| Blood gas analysis | Two blood gas analysis will be done, one at the beginning and one at the end of the 45-minyte NIV treatment. | 45 minutes | 
| Patient comfort | Patient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10. | 45 minutes | 
| Percentage of time spent in a predifined comfort zone. | The comfort zone will be defined as respiratory rate between 14 and 29 breaths/minunte and tidal volume between 5 and 10 ml/ kg IBW | 45 minutes | 
| Heart rate |  | 45 minutes | 
| Blood pressure |  | 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non invasive ventilation, Computer-driven system, Acute respiratory failure