Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation

NCT02883465 | Completed

• 1 other identifier: SJSL12014
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Mechanical Ventilation Weaning

Keywords

diaphragmatic dysfunction; mechanical ventilation weaning; failure extubation rate

Outcome Measures

Primary Outcomes (1)

• Extubation success rate

  Extubation success rate, defined as no reintubation 7 days after the reporting extubation

  7 days after the reported extubation

Secondary Outcomes (13)

• 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

  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

  At the extubation time

Study Arms (1)

Single arm

OTHER

Procedure: Diaphragmatic ultrasound

Interventions

Diaphragmatic ultrasound PROCEDURE

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Saint Joseph Saint Luc de Lyon: lead
• Poitiers University Hospital: collaborator

Study Sites (3)

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: August 30, 2016
• Study Start: March 6, 2015
• Primary Completion: October 28, 2016
• Study Completion: November 1, 2016
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

FR (3)