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

Centre Hospitalier Saint Joseph Saint Luc de Lyon3 sites in 1 country74 target enrollmentMarch 6, 2015

ConditionsMechanical Ventilation Weaning

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mechanical Ventilation Weaning
Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Enrollment: 74
Locations: 3
Primary Endpoint: Extubation success rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 6, 2015

End Date

November 1, 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Length of stay in reanimation unit (days)(At discharge of reanimation unit (up to 1 year))
Length of mechanical ventilation(At the extubation time)
Mortality(At discharge of reanimation unit (up to 1 year))
Number of patients with invasive or non-invasive mechanical ventilation(48 hours after the extubation)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : quantity of secretions measured with a defined scale(At the extubation time)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a clinical parameter : presence/absence or cervical tonus(At 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 : maximal inspiratory pressure in centimeters of water(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 clinical parameter : cough strength measured with a defined scale(At the extubation time)
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)
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)
Comparison between the predictive value of diaphragmatic ultrasound dysfunction and a paraclinical parameter : P0,1 measured in milliseconds(At the extubation time)