Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI) (CODEX)
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ClinicalTrials.gov Identifier: NCT03479047 |
Recruitment Status :
Completed
First Posted : March 27, 2018
Last Update Posted : May 6, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
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Mechanical Ventilation Mechanical Ventilator Weaning Extubation Diaphragm Ultrasound | Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the Rapid Shallow Breathing Index |
Actual Study Start Date : | March 23, 2018 |
Actual Primary Completion Date : | January 16, 2019 |
Actual Study Completion Date : | January 16, 2019 |
Arm | Intervention/treatment |
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Experimental: Ventilated patients
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.
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Diagnostic Test: 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. |
- Difference between the RSBI area and the RSDI AUC [ Time Frame: 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.
- Find a cut-off value for RSDI [ Time Frame: 72 hours post-extubation ]- Find a cut-off value for RSDI with the best predicting accuracy for the weaning
- Compare traditional RSBI values recorded with scientific publications [ Time Frame: 72 hours post-extubation ]
- Find reasons for non-extubation when criteria are gathered [ Time Frame: 72 hours post-extubation ]
- Estimate average duration of mechanical ventilation in central nervous system disorder patient [ Time Frame: 72 hours post-extubation ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479047
France | |
CHR d'Orléans | |
Orléans, France, 45067 |
Principal Investigator: | Guillaume FOSSAT | CHR Orléans |
Responsible Party: | Centre Hospitalier Régional d'Orléans |
ClinicalTrials.gov Identifier: | NCT03479047 |
Other Study ID Numbers: |
CHRO-2018-02 |
First Posted: | March 27, 2018 Key Record Dates |
Last Update Posted: | May 6, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
diaphragm ultrasound spontaneous breathing trial mechanical ventilation weaning rapid shallow breathing index |