Clinical trial NCT02883465: Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation
Official title: Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation and Influence Over Mechanical Ventilation Weaning Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Weaning
Keywords: diaphragmatic dysfunction
mechanical ventilation weaning
failure extubation rate
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
Collaborators: name: Poitiers University Hospital
First posted: 2016-08-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Extubation success rate
timeFrame: 7 days after the reported extubation
Secondary outcomes:
measure: Length of stay in reanimation unit (days)
timeFrame: At discharge of reanimation unit (up to 1 year)
measure: Length of mechanical ventilation
timeFrame: At the extubation time
measure: Number of patients with invasive or non-invasive mechanical ventilation
timeFrame: 48 hours after the extubation
measure: Mortality
timeFrame: At discharge of reanimation unit (up to 1 year)
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : cough strength measured with a defined scale
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : F/Vt ratio measured in breaths/min/L
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : maximal inspiratory pressure in centimeters of water
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : minimal expiratory pressure measured in centimeters of water
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow measured in L/min (liters per minute)
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : peak flow when coughing measured in L/min (liters per minute)
timeFrame: At the extubation time
measure: Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds
timeFrame: At the extubation time
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
Study officials:
References: