BEACON Care ® System Assisting Ventilation in Pressure Support Ventilation (PSV) Patient (BEACON3)

May 2, 2018 updated by: Savino Spadaro, Università degli Studi di Ferrara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • Azienda Ospedaliero Universitaria Sant'Anna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Under mechanical ventilation in Pressure Support mode

Exclusion Criteria:

  • Neuromuscular impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pressure Support Over Support
Pressure Support Level upward by 50%, 2 hours
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
Other: Pressure Support Under Support
Pressure Support Level downward by 50%, 2 hours
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
Other: PEEP Over Level
PEEP Level upward 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
Other: PEEP Under Level
PEEP 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Collaborators

Aalborg University

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20150604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Artificial Respiration

Clinical Trials on Pressure Support Over Support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe