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.

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Adult Intensive Care and Burn Unit, University hospital of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Philippe Jolliet, Prof, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: June 2, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Non invasive ventilation; Acute respiratory failure; Computer-driven system
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: SmartCare/PS-NIV