SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

NCT01870089 | Terminated

• 1 other identifier: SmartCare/PS-NIV
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Respiratory rate

  45 minutes

• Minute ventilation

  45 minutes

• Tidal volumes

  45 minutes

• Leaks

  45 minutes

• O2 saturation

  45 minutes

Study Arms (1)

Study group

EXPERIMENTAL

Device: SmartCare/PS-NIV Drägerwerk Lübeck Germany

Interventions

SmartCare/PS-NIV Drägerwerk Lübeck Germany DEVICE

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory failure requiring non invasive ventilation
• ICU patient equipped with an arterial line.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Adult Intensive Care and Burn unit, University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Study Officials

• Philippe Jolliet, Prof

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 5, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CH (1)