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Trial record 3 of 21 for:    CODEX

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

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

Tracking Information
First Submitted Date  ICMJE March 20, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE March 23, 2018
Actual Primary Completion Date January 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03479047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • 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
  • Compare traditional RSBI values recorded with scientific publications [ Time Frame: 72 hours post-extubation ]
  • Find reasons for non-extubation when criteria are gathered [ Time Frame: 72 hours post-extubation ]
  • Estimate average duration of mechanical ventilation in central nervous system disorder patient [ Time Frame: 72 hours post-extubation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI)
Official Title  ICMJE Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Mechanical Ventilation
  • Mechanical Ventilator Weaning
  • Extubation
  • Diaphragm Ultrasound
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Diagnostic Test: assess diaphragmatic displacement (DD) using ultrasonography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 16, 2019
Actual Primary Completion Date January 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03479047
Other Study ID Numbers  ICMJE CHRO-2018-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Régional d'Orléans
Study Sponsor  ICMJE Centre Hospitalier Régional d'Orléans
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guillaume FOSSAT CHR Orléans
PRS Account Centre Hospitalier Régional d'Orléans
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP