SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study
- Conditions
- Acute Respiratory Failure
- Interventions
- Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany
- Registration Number
- NCT01870089
- Lead Sponsor
- University of Lausanne Hospitals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- Acute respiratory failure requiring non invasive ventilation
- ICU patient equipped with an arterial line.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study group SmartCare/PS-NIV Drägerwerk Lübeck Germany -
- Primary Outcome Measures
Name Time Method Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure. 45 minute NIV-treatment 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.
- Secondary Outcome Measures
Name Time Method Leaks 45 minutes O2 saturation 45 minutes Transcutaneous measurement
Blood gas analysis 45 minutes Two blood gas analysis will be done, one at the beginning and one at the end of the 45-minyte NIV treatment.
Tidal volumes 45 minutes Alarms generated by the ventilator 45 minutes Blood pressure 45 minutes Respiratory rate 45 minutes Manual ventilator settings modifications required 45 minutes Heart rate 45 minutes Minute ventilation 45 minutes Patient-ventilator asynchronies 45 minutes Patient comfort 45 minutes Patient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10.
Percentage of time spent in a predifined comfort zone. 45 minutes 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
Trial Locations
- Locations (1)
Adult Intensive Care and Burn unit, University Hospital of Lausanne
🇨🇭Lausanne, Switzerland