Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03479047
Acronym
CODEX
Enrollment
100
Registered
2018-03-27
Start date
2018-03-23
Completion date
2019-01-16
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Ultrasound, Extubation, Mechanical Ventilation, Mechanical Ventilator Weaning

Keywords

diaphragm ultrasound, spontaneous breathing trial, mechanical ventilation weaning, rapid shallow breathing index

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.

Interventions

DIAGNOSTIC_TESTassess 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.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Difference between the RSBI area and the RSDI AUC72 hours post-extubationDifference between the RSBI area under the receiving operator character curve (AUC) and the RSDI AUC in predicting success of mechanical ventilation weaning.

Secondary

MeasureTime frameDescription
Find a cut-off value for RSDI72 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 publications72 hours post-extubation
Find reasons for non-extubation when criteria are gathered72 hours post-extubation
Estimate average duration of mechanical ventilation in central nervous system disorder patient72 hours post-extubation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026