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Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02883465
Acronym
ECHODIAPH II
Enrollment
74
Registered
2016-08-30
Start date
2015-03-06
Completion date
2016-11-01
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Weaning

Keywords

diaphragmatic dysfunction, mechanical ventilation weaning, failure extubation rate

Brief summary

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.

Interventions

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

Sponsors

Poitiers University Hospital
CollaboratorOTHER
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Extubation success rate7 days after the reported extubationExtubation success rate, defined as no reintubation 7 days after the reporting extubation

Secondary

MeasureTime frameDescription
Length of mechanical ventilationAt the extubation time
Number of patients with invasive or non-invasive mechanical ventilation48 hours after the extubationResort to invasive or non-invasive mechanical ventilation
MortalityAt discharge of reanimation unit (up to 1 year)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scaleAt the extubation timeThe scale used to measure the cough is the following : * absent * inefficient * low efficiency * mild efficiency * efficient
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scaleAt the extubation time* any secretions * low secretions * mild secretions * abundant secretions * very abundant secretions
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonusAt the extubation time
Length of stay in reanimation unit (days)At discharge of reanimation unit (up to 1 year)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of waterAt the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of waterAt the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)At the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in millisecondsAt the extubation time
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/LAt the extubation time

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026