Ultrasound Study of the Diaphragm Evolution Under ECMO

NCT03736239 | Completed

• 1 other identifier: 3-2018-DIAGECMO
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients.

Conditions

Cardiogenic Shock; Weaning Failure

Keywords

ECMO; Intensive Care Units; Shock, Cardiogenic; Ventilator Weaning; Diaphragm; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Evaluate the evolution of the diaphragm muscle effort in cardiogenic shock during the first ECLS weaning in patients in ICU.

  The performance of the diaphragm muscle will be evaluated by ultrasonography (the thickening fraction of the diaphragm) during the weaning of the ECMO at different weaning level : after 15 minutes (Baseline, 4 l/min, 2 l / min, 1 l / min). Wash out of 10 min between each measurement. The parameters of the assisted ventilation will be standardized according to the practices of the service and recommendations.

  at 15 min

Secondary Outcomes (7)

• Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of diaphragm muscle thickness

  at 15 min

• Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of the function of the diaphragm muscle

  at 15 min

• Evaluate the impact of different risk factors on the diaphragmatic function

  previous exposure before inclusion

• Evaluate the impact of the diaphragmatic function on the patient's future: failure to wean from mechanical ventilation

  at 60 days

• Evaluate the impact of the diaphragmatic function on the patient's future: ECLS weaning failure

  at 60 days

Eligibility Criteria

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

Study Population

Patients will be recruited into the intensive care unit of the investigating center, under the responsibility of the principal investigator of the study. All patients admitted to intensive care present cardiogenic shock. After verification of the inclusion and non-inclusion criteria, the information on the diagnostic procedures will be given by one of the investigators. Due to the observational nature of the research, patients can participate in another one. There is not an exclusion period at the end of the search.

You may qualify if:

• Patient hospitalized in intensive care for cardiogenic shock under ECMO (extracorporeal membrane oxygenator)
• Veno-arterial ECMO
• ECMO withdrawal decision
• Patient or family agreeing to participate in research

You may not qualify if:

• Patient under guardianship or curatorship
• Contraindication to spontaneous ventilation
• Pregnant woman
• Anechoic patient for diaphragmatic ultrasound

Sponsors & Collaborators

• Association Pro-arte: lead

Study Sites (1)

CHU Grenoble Alpes

La Tronche, 38043, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Pierre-Henri Moury

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: November 9, 2018
• Study Start: June 15, 2018
• Primary Completion: April 3, 2019
• Study Completion: June 5, 2019
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

FR (1)