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

NCT ID: NCT02760147

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Artificial Respiration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pressure Support Over Support

Pressure Support Level upward by 50%, 2 hours

Group Type OTHER

Pressure Support Over Support

Intervention Type DEVICE

Pressure Support Level upward by 50%, 2 hours

Pressure Support Under Support

Intervention Type DEVICE

Pressure Support Level downward by 50%, 2 hours

Pressure Support Under Support

Pressure Support Level downward by 50%, 2 hours

Group Type OTHER

Pressure Support Over Support

Intervention Type DEVICE

Pressure Support Level upward by 50%, 2 hours

Pressure Support Under Support

Intervention Type DEVICE

Pressure Support Level downward by 50%, 2 hours

PEEP Over Level

PEEP Level upward by 50%, 2 hours

Group Type OTHER

PEEP Over Level

Intervention Type DEVICE

PEEP Level upward by 50%, 2 hours

PEEP Under Level

Intervention Type DEVICE

PEEP Level downward by 50%, 2 hours

PEEP Under Level

PEEP Level downward by 50%, 2 hours

Group Type OTHER

PEEP Over Level

Intervention Type DEVICE

PEEP Level upward by 50%, 2 hours

PEEP Under Level

Intervention Type DEVICE

PEEP Level downward by 50%, 2 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pressure Support Over Support

Pressure Support Level upward by 50%, 2 hours

Intervention Type DEVICE

Pressure Support Under Support

Pressure Support Level downward by 50%, 2 hours

Intervention Type DEVICE

PEEP Over Level

PEEP Level upward by 50%, 2 hours

Intervention Type DEVICE

PEEP Under Level

PEEP Level downward by 50%, 2 hours

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Under mechanical ventilation in Pressure Support mode

Exclusion Criteria

* Neuromuscular impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aalborg University

OTHER

Sponsor Role collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Savino Spadaro

Assistant Professor - Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephen Rees, Medical

Role: STUDY_DIRECTOR

Aalborg University

Dan Stieper Karbing, Engenieer

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Savino Spadaro, Medicine

Role: PRINCIPAL_INVESTIGATOR

Ferrara University

Carlo Alberto Volta, Medicine

Role: STUDY_DIRECTOR

Ferrara University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20150604

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.