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SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01870089
Enrollment
11
Registered
2013-06-05
Start date
2013-05-31
Completion date
2016-08-31
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Non invasive ventilation, Computer-driven system, Acute respiratory failure

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.

Interventions

DEVICESmartCare/PS-NIV Drägerwerk Lübeck Germany

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibilty of using the Smartcare-NIV system to deliver non-invasive ventilation in case of acute respiratory failure.45 minute NIV-treatmentThe 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

MeasureTime frameDescription
Patient comfort45 minutesPatient comfort will be evaluated usuing a visual analogic scale graduated between 0 and 10.
Respiratory rate45 minutes
Minute ventilation45 minutes
Tidal volumes45 minutes
Leaks45 minutes
O2 saturation45 minutesTranscutaneous measurement
Blood gas analysis45 minutesTwo blood gas analysis will be done, one at the beginning and one at the end of the 45-minyte NIV treatment.
Manual ventilator settings modifications required45 minutes
Patient-ventilator asynchronies45 minutes
Percentage of time spent in a predifined comfort zone.45 minutesThe comfort zone will be defined as respiratory rate between 14 and 29 breaths/minunte and tidal volume between 5 and 10 ml/ kg IBW
Heart rate45 minutes
Blood pressure45 minutes
Alarms generated by the ventilator45 minutes

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026