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Completed

NCT Number: NCT02760147

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

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.

Completed

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Key information

Conditions

Artificial Respiration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Under mechanical ventilation in Pressure Support mode

Exclusion criteria

  • Neuromuscular impairment

Treatment and study plan

Pressure Support Over Support

Device

Pressure Support Level upward by 50%, 2 hours

Pressure Support Under Support

Device

Pressure Support Level downward by 50%, 2 hours

PEEP Over Level

Device

PEEP Level upward by 50%, 2 hours

PEEP Under Level

Device

PEEP Level downward by 50%, 2 hours

Primary outcomes

  1. Reduction of respiratory fatigue of patient under mechanical ventilation

    Time frame: Average of 1 hour

    Esophageal catheter will be positioned and pressure generated by the respiratory muscles will be measured to detect respiratory muscles' fatigue.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Acronym: BEACON3

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
May 3, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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