NCT02760147

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Artificial Respiration

Interventions

Type	Name	Description
DEVICE	Pressure Support Over Support	Pressure Support Level upward by 50%, 2 hours
DEVICE	Pressure Support Under Support	Pressure Support Level downward by 50%, 2 hours
DEVICE	PEEP Over Level	PEEP Level upward by 50%, 2 hours
DEVICE	PEEP Under Level	PEEP Level downward by 50%, 2 hours

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-08-01
• Completion: 2017-03-01
• First posted: 2016-05-03
• Last updated: 2018-05-03

Locations

1 site across 1 country: Italy