SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

NCT ID: NCT01870089

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Group Type: EXPERIMENTAL

SmartCare/PS-NIV Drägerwerk Lübeck Germany

Intervention Type: DEVICE

Interventions

SmartCare/PS-NIV Drägerwerk Lübeck Germany

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Prof. Philippe Jolliet

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Jolliet, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

Adult Intensive Care and Burn unit, University Hospital of Lausanne

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

SmartCare/PS-NIV

Identifier Type: -

Identifier Source: org_study_id