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

NCT03479047 | Completed

• 1 other identifier: CHRO-2018-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Mechanical Ventilator Weaning; Extubation; Diaphragm Ultrasound

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Find a cut-off value for RSDI

  72 hours post-extubation

• Compare traditional RSBI values recorded with scientific publications

  72 hours post-extubation

• 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

Study Arms (1)

Ventilated patients

EXPERIMENTAL

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.

Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography

Interventions

assess diaphragmatic displacement (DD) using ultrasonography DIAGNOSTIC_TEST

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.

Ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (5)

• 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.

  PMID: 27677861 BACKGROUND

• 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.

  PMID: 24365607 BACKGROUND

• 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.

  PMID: 27112953 BACKGROUND

• 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.

  PMID: 19017880 BACKGROUND

• 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.

  PMID: 27832242 BACKGROUND

Study Officials

• Guillaume FOSSAT

  CHR Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: March 23, 2018
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)