SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

Acute Respiratory Failure Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01870089
• Other study ID #: SmartCare/PS-NIV
• Status: Terminated
• Phase: N/A
• First received: May 23, 2013
• Last updated: May 3, 2017
• Start date: May 2013
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• SmartCare/PS-NIV Drägerwerk Lübeck Germany

Locations

Country	Name	City	State
Switzerland	Adult Intensive Care and Burn unit, University Hospital of Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory rate		45 minutes
Secondary	Minute ventilation		45 minutes
Secondary	Tidal volumes		45 minutes
Secondary	Leaks		45 minutes
Secondary	O2 saturation	Transcutaneous measurement	45 minutes
Secondary	Alarms generated by the ventilator		45 minutes
Secondary	Manual ventilator settings modifications required		45 minutes
Secondary	Patient-ventilator asynchronies		45 minutes
Secondary	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
Secondary	Patient comfort	Patient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10.	45 minutes
Secondary	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
Secondary	Heart rate		45 minutes
Secondary	Blood pressure		45 minutes