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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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479047


Locations
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France
CHR d'Orléans
Orléans, France, 45067
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Guillaume FOSSAT CHR Orléans

Publications:
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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    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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