BEACON Care ® System Assisting Ventilation in Pressure Support Ventilation (PSV) Patient
BEACON3
Evaluation of Beacon Care System Advice in Pressure Support: Does the System Maintain Patients Within Appropriate Levels of Support?
1 other identifier
interventional
85
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 28, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 3, 2018
May 1, 2018
1 month
April 28, 2016
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Pressure Support Over Support
OTHERPressure Support Level upward by 50%, 2 hours
Pressure Support Under Support
OTHERPressure Support Level downward by 50%, 2 hours
PEEP Over Level
OTHERPEEP Level upward by 50%, 2 hours
PEEP Under Level
OTHERPEEP Level downward by 50%, 2 hours
Interventions
Pressure Support Level upward by 50%, 2 hours
Pressure Support Level downward by 50%, 2 hours
Eligibility Criteria
You may qualify if:
- Under mechanical ventilation in Pressure Support mode
You may not qualify if:
- Neuromuscular impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università degli Studi di Ferraralead
- Aalborg Universitycollaborator
Study Sites (1)
Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, 44121, Italy
Study Officials
- STUDY DIRECTOR
Stephen Rees, Medical
Aalborg University
- PRINCIPAL INVESTIGATOR
Dan Stieper Karbing, Engenieer
Aalborg University
- PRINCIPAL INVESTIGATOR
Savino Spadaro, Medicine
Ferrara University
- STUDY DIRECTOR
Carlo Alberto Volta, Medicine
Ferrara University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor - Researcher
Study Record Dates
First Submitted
April 28, 2016
First Posted
May 3, 2016
Study Start
July 1, 2015
Primary Completion
August 1, 2015
Study Completion
March 1, 2017
Last Updated
May 3, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share