Clinical trial NCT03479047: Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI)
Official title: Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the Rapid Shallow Breathing Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Mechanical Ventilator Weaning
Extubation
Diaphragm Ultrasound
Keywords: diaphragm ultrasound
spontaneous breathing trial
mechanical ventilation weaning
rapid shallow breathing index
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between the RSBI area and the RSDI AUC
timeFrame: 72 hours post-extubation
Secondary outcomes:
measure: Find a cut-off value for RSDI
timeFrame: 72 hours post-extubation
measure: Compare traditional RSBI values recorded with scientific publications
timeFrame: 72 hours post-extubation
measure: Find reasons for non-extubation when criteria are gathered
timeFrame: 72 hours post-extubation
measure: Estimate average duration of mechanical ventilation in central nervous system disorder patient
timeFrame: 72 hours post-extubation
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR Orléans
name: Guillaume FOSSAT
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1186/s13054-016-1479-y.
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.
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.
citation: 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.
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. No abstract available.