Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI)

Study Overview
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Brief Summary
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The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm. Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as: RSDI = RSBI/DD. The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to predict weaning success in ready-to-wean patients.

Official Title
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Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the Rapid Shallow Breathing Index

Conditions
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Mechanical Ventilation, Mechanical Ventilator Weaning, Extubation, Diaphragm Ultrasound

Intervention / Treatment
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* Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Mechanically ventilated patient > 24 hours Weaning ventilator phase (PEEP < 9 cmH2O and Support < 15 cm H2O) Ventilated via tracheostomy tube patient can be included on removal day of the cannula Patient's agreement to participate Exclusion Criteria: Moribund patient Decision to forgo life sustaining therapy patient Patient with ventilation via tracheostomy tube before admission to ICU BMI > 45

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilated patients<br>During a spontaneous breathing trial (SBT) we will simultaneously, for all included patient, assess diaphragmatic displacement (DD) using ultrasonography, respiratory rate (RR) and tidal volume (VT) on ventilator screen. | Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography<br>* During a spontaneous breathing trial (SBT) we will simultaneously, for all included patient, assess diaphragmatic displacement (DD) using ultrasonography, respiratory rate (RR) and tidal volume (VT) on ventilator screen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the RSBI area and the RSDI AUC | Difference between the RSBI area under the receiving operator character curve (AUC) and the RSDI AUC in predicting success of mechanical ventilation weaning. | 72 hours post-extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Find a cut-off value for RSDI | - Find a cut-off value for RSDI with the best predicting accuracy for the weaning | 72 hours post-extubation | 
| Compare traditional RSBI values recorded with scientific publications |  | 72 hours post-extubation | 
| Find reasons for non-extubation when criteria are gathered |  | 72 hours post-extubation | 
| Estimate average duration of mechanical ventilation in central nervous system disorder patient |  | 72 hours post-extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diaphragm ultrasound, spontaneous breathing trial, mechanical ventilation weaning, rapid shallow breathing index