Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

Not Applicable

Completed

• Conditions: Mechanical Ventilation Weaning
• Interventions: Procedure: Diaphragmatic ultrasound

• Registration Number: NCT02883465
• Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-06
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2016-10-28
• Study Completion: 2016-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Diaphragmatic ultrasound	-

Primary Outcome Measures

Name	Time	Method
Extubation success rate	7 days after the reported extubation	Extubation success rate, defined as no reintubation 7 days after the reporting extubation

Secondary Outcome Measures

Name	Time	Method
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	Resort to invasive or non-invasive mechanical ventilation
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	* 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 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 : 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	The 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 : 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 : maximal inspiratory pressure in centimeters of water	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

Trial Locations

Locations (3)

Centre Hospitalier Annecy Genevois; 🇫🇷 Metz-Tessy, France

Centre Hospitalier Saint Joseph Saint Luc; 🇫🇷 Lyon, France

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France