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

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Diaphragm Ultrasound; Extubation; Mechanical Ventilator Weaning
• Interventions: Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography

• Registration Number: NCT03479047
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study Start: 2018-03-23
• Study First Posted: 2018-03-27
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Moribund patient
• Decision to forgo life sustaining therapy patient
• Patient with ventilation via tracheostomy tube before admission to ICU
• BMI > 45

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ventilated patients	assess diaphragmatic displacement (DD) using ultrasonography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare traditional RSBI values recorded with scientific publications	72 hours post-extubation
Find a cut-off value for RSDI	72 hours post-extubation	- Find a cut-off value for RSDI with the best predicting accuracy for the weaning
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

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France