Clinical trial NCT01870089: SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Non invasive ventilation
Computer-driven system
Acute respiratory failure
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.
timeFrame: 45 minute NIV-treatment
Secondary outcomes:
measure: Respiratory rate
timeFrame: 45 minutes
measure: Minute ventilation
timeFrame: 45 minutes
measure: Tidal volumes
timeFrame: 45 minutes
measure: Leaks
timeFrame: 45 minutes
measure: O2 saturation
timeFrame: 45 minutes
measure: Alarms generated by the ventilator
timeFrame: 45 minutes
measure: Manual ventilator settings modifications required
timeFrame: 45 minutes
measure: Patient-ventilator asynchronies
timeFrame: 45 minutes
measure: Blood gas analysis
timeFrame: 45 minutes
measure: Patient comfort
timeFrame: 45 minutes
measure: Percentage of time spent in a predifined comfort zone.
timeFrame: 45 minutes
measure: Heart rate
timeFrame: 45 minutes
measure: Blood pressure
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Adult Intensive Care and Burn unit, University Hospital of Lausanne
Study officials:
affiliation: University of Lausanne Hospitals
name: Philippe Jolliet, Prof
role: PRINCIPAL_INVESTIGATOR
References: