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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Artificial Respiration

Intervention / Treatment
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* Device: Pressure Support Over Support
* Device: Pressure Support Under Support
* Device: PEEP Over Level
* Device: PEEP Under Level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under mechanical ventilation in Pressure Support mode Exclusion Criteria: Neuromuscular impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pressure Support Over Support<br>Pressure Support Level upward by 50%, 2 hours | Device: Pressure Support Over Support<br>* Pressure Support Level upward by 50%, 2 hours<br>Device: Pressure Support Under Support<br>* Pressure Support Level downward by 50%, 2 hours<br>|
| Other: Pressure Support Under Support<br>Pressure Support Level downward by 50%, 2 hours | Device: Pressure Support Over Support<br>* Pressure Support Level upward by 50%, 2 hours<br>Device: Pressure Support Under Support<br>* Pressure Support Level downward by 50%, 2 hours<br>|
| Other: PEEP Over Level<br>PEEP Level upward by 50%, 2 hours | Device: PEEP Over Level<br>* PEEP Level upward by 50%, 2 hours<br>Device: PEEP Under Level<br>* PEEP Level downward by 50%, 2 hours<br>|
| Other: PEEP Under Level<br>PEEP Level downward by 50%, 2 hours | Device: PEEP Over Level<br>* PEEP Level upward by 50%, 2 hours<br>Device: PEEP Under Level<br>* PEEP Level downward by 50%, 2 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure Support Ventilation