Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

Mechanical Ventilation Weaning Clinical Trial

— ECHODIAPH II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883465
• Other study ID #: SJSL12014
• Status: Completed
• Phase: N/A
• Start date: March 6, 2015
• Est. completion date: November 1, 2016

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 1, 2016
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Weaning

Intervention

Procedure:
• Diaphragmatic ultrasound
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

Locations

Country	Name	City	State
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Centre Hospitalier Annecy Genevois	Metz-Tessy
France	Centre Hospitalier Universitaire de Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon	Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation success rate	Extubation success rate, defined as no reintubation 7 days after the reporting extubation	7 days after the reported extubation
Secondary	Length of stay in reanimation unit (days)		At discharge of reanimation unit (up to 1 year)
Secondary	Length of mechanical ventilation		At the extubation time
Secondary	Number of patients with invasive or non-invasive mechanical ventilation	Resort to invasive or non-invasive mechanical ventilation	48 hours after the extubation
Secondary	Mortality		At discharge of reanimation unit (up to 1 year)
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale	The scale used to measure the cough is the following : absent; inefficient; low efficiency; mild efficiency; efficient	At the extubation time
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale	any secretions; low secretions; mild secretions; abundant secretions; very abundant secretions	At the extubation time
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus		At the extubation time
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L		At the extubation time
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water		At the extubation time
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water		At the extubation time
Secondary	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
Secondary	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
Secondary	Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds		At the extubation time