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Completed

NCT Number: NCT03479047

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

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.

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Key information

Conditions

Mechanical Ventilation Diaphragm Ultrasound Extubation Mechanical Ventilator Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orléans

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the Rapid Shallow Breathing Index

Acronym: CODEX

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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