BEACON Care ® System Assisting Ventilation in Pressure Support Ventilation (PSV) Patient

Artificial Respiration Clinical Trial

— BEACON3  

Official title:

Evaluation of Beacon Care System Advice in Pressure Support: Does the System Maintain Patients Within Appropriate Levels of Support?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760147
• Other study ID #: 20150604
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2018
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the ventilator settings advice given by the BEACON care system in fitting with best level of support in patient under mechanical ventilation in Pressure Support mode.

Description:

The purpose of this study is to evaluate whether pressure support settings suggested by the B3 system and pressure support as well as Positive End Expiratory Pressure (PEEP) settings suggested by the B5 system, i.e. balancing under and over support based upon physiological models and simple clinical measures, are consistent with keeping patients within appropriate levels of support as assessed by the ratio between airwaiy pressure generated by the respiratory muscles (Pmus) and the maximum inspiratory pressure (MIP) (Pmus/MIP), the ratio between the inspiratory time (TI) and total respiratory time (TTOT) (TI/TTOT) and the Tension-Time index (TTi), these being obtained using less frequently used esophageal catheter measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Under mechanical ventilation in Pressure Support mode

Exclusion Criteria:

• Neuromuscular impairment

Related Conditions & MeSH terms

• Artificial Respiration

Intervention

Device:
• Pressure Support Over Support
Pressure Support Level upward by 50%, 2 hours
• Pressure Support Under Support
Pressure Support Level downward by 50%, 2 hours
• PEEP Over Level
PEEP Level upward by 50%, 2 hours
• PEEP Under Level
PEEP Level downward by 50%, 2 hours

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	Aalborg University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of respiratory fatigue of patient under mechanical ventilation	Esophageal catheter will be positioned and pressure generated by the respiratory muscles will be measured to detect respiratory muscles' fatigue.	Average of 1 hour