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

• ClinicalTrials.gov Identifier: NCT03479047
• Recruitment Status: Completed
• First Posted: March 27, 2018
• Last Update Posted: May 6, 2019
• Sponsor: Centre Hospitalier Régional d'Orléans
• Information provided by (Responsible Party): Centre Hospitalier Régional d'Orléans

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mechanical Ventilation; Mechanical Ventilator Weaning; Extubation; Diaphragm Ultrasound	Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. Compare traditional RSBI values recorded with scientific publications [ Time Frame: 72 hours post-extubation ]
3. Find reasons for non-extubation when criteria are gathered [ Time Frame: 72 hours post-extubation ]
4. Estimate average duration of mechanical ventilation in central nervous system disorder patient [ Time Frame: 72 hours post-extubation ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

CHR d'Orléans

Orléans, France, 45067

Sponsors and Collaborators

Centre Hospitalier Régional d'Orléans

Investigators

• Principal Investigator: Guillaume FOSSAT; CHR Orléans

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: Centre Hospitalier Régional d'Orléans
• ClinicalTrials.gov Identifier: NCT03479047 History of Changes
• Other Study ID Numbers: CHRO-2018-02
• First Posted: March 27, 2018
• 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

Keywords provided by Centre Hospitalier Régional d'Orléans:

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