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Completed

NCT Number: NCT02883465

Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

Extubation is a crucial step when patients are being weaned from mechanical ventilator support. Indeed, the patient has to face an increasing burden imposed to the ventilation system. The ability to overcome this event will determine the patient survival. A warning signal could be very useful is this situation. 2 recent studies have shown that measuring diaphragmatic cupolas and muscular fibers thickening fraction could help to spot a population with a high risk of "diaphragmatic weakness", characterized by a high failure extubation rate. This study aims to verify that this kind of group of patients does exist.

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Key information

Conditions

Mechanical Ventilation Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Saint Joseph Saint Luc, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Successful spontaneous breathing trial and extubation expected on the same day and 1 of the following criteria :
  • Age > 65
  • Mechanical ventilation during > 7 days
  • Cardiac history (ischemic, rhythmic or valve cardiopathy)
  • Respiratory history (documented or likely chronic respiratory failure)

Exclusion criteria

  • Patient who is tracheotomized
  • Peripheric neuromuscular disease (myasthenia, myopathy)
  • Surgery circumstances that could affect the quality of the ultrasound exam (drains or bandages)
  • Pregnant woman
  • Age < 18

Treatment and study plan

Diaphragmatic ultrasound

Procedure

All patients will have a diaphragmatic ultrasound in the 4 hours before the extubation.

  • a record of the right and left diaphragmatic cupolas run, with a chest approach and using a 4-5 MHz (megahertz) cardiac or abdominal sensor. 3 acquisitions for each side
  • a record of the diaphragm thickening at the right and left apposition zones with a 10-12 MHz (megahertz) vascular sensor. 3 acquisitions for each side

Primary outcomes

  1. Extubation success rate

    Time frame: 7 days after the reported extubation

    Extubation success rate, defined as no reintubation 7 days after the reporting extubation

Secondary outcomes

  1. Length of stay in reanimation unit (days)

    Time frame: At discharge of reanimation unit (up to 1 year)

  2. Length of mechanical ventilation

    Time frame: At the extubation time

  3. Number of patients with invasive or non-invasive mechanical ventilation

    Time frame: 48 hours after the extubation

    Resort to invasive or non-invasive mechanical ventilation

  4. Mortality

    Time frame: At discharge of reanimation unit (up to 1 year)

  5. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale

    Time frame: At the extubation time

    The scale used to measure the cough is the following :

    • absent
    • inefficient
    • low efficiency
    • mild efficiency
    • efficient

  6. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale

    Time frame: At the extubation time

    • any secretions
    • low secretions
    • mild secretions
    • abundant secretions
    • very abundant secretions

  7. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus

    Time frame: At the extubation time

  8. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L

    Time frame: At the extubation time

  9. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water

    Time frame: At the extubation time

  10. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water

    Time frame: At the extubation time

  11. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)

    Time frame: At the extubation time

  12. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)

    Time frame: At the extubation time

  13. Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds

    Time frame: At the extubation time

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Collaborators

  • Poitiers University Hospital

Registry information

Official study title

Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period

Acronym: ECHODIAPH II

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Apr 4, 2024

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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