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

Mechanical Ventilation Clinical Trial

— CODEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479047
• Other study ID #: CHRO-2018-02
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: January 16, 2019

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Ultrasound
• Extubation
• Mechanical Ventilation
• Mechanical Ventilator Weaning

Intervention

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.

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (5)

Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18. — View Citation

DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23. — View Citation

Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22. — View Citation

Forgiarini LA Junior, Esquinas AM. The rapid shallow breathing index as a predictor of successful mechanical ventilation weaning: clinical utility when calculated from ventilator data. J Bras Pneumol. 2016 Jul-Aug;42(4):306. doi: 10.1590/S1806-37562016000000099. English, Portuguese. — View Citation

Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Compare traditional RSBI values recorded with scientific publications		72 hours post-extubation
Secondary	Find reasons for non-extubation when criteria are gathered		72 hours post-extubation
Secondary	Estimate average duration of mechanical ventilation in central nervous system disorder patient		72 hours post-extubation