Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation (ECHODIAPH II)

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Weaning
• Intervention / Treatment: Procedure: Diaphragmatic ultrasound

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel Vivier; Email: evivier@ch-stjoseph-stluc-lyon.fr
• Study Contact Backup: Name: Stéphane Rio; Phone Number: +33478618216; Email: srio@ch-stjoseph-stluc-lyon.fr

Study Locations

• France
  • Lyon, France, 69007
    • Centre Hospitalier Saint Joseph Saint Luc
  • Metz-Tessy, France, 74374
    • Centre Hospitalier Annecy Genevois
  • Poitiers, France, 86021
    • Centre Hospitalier Universitaire de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single arm

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation success rate	Extubation success rate, defined as no reintubation 7 days after the reporting extubation	7 days after the reported extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in reanimation unit (days)		At discharge of reanimation unit (up to 1 year)
Length of mechanical ventilation		At the extubation time
Number of patients with invasive or non-invasive mechanical ventilation	Resort to invasive or non-invasive mechanical ventilation	48 hours after the extubation
Mortality		At 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 scale	The scale used to measure the cough is the following : absent; inefficient; low efficiency; mild efficiency; efficient	At the extubation time
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
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 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 : 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 milliseconds		At the extubation time

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Collaborators: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2015
• Primary Completion (Actual): October 28, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimated): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: mechanical ventilation weaning; diaphragmatic dysfunction; failure extubation rate
• Other Study ID Numbers: SJSL12014