Ultrasound Study of the Diaphragm Evolution Under ECMO (DIAG-ECMO)

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

Study Overview

• Status: Completed
• Conditions: Cardiogenic Shock; Weaning Failure

Detailed Description

Diaphragmatic atrophy and diaphragmatic dysfunction are described in human resuscitation under mechanical ventilation, but this diaphragmatic function has not been studied in patients with cardiogenic shock and also under cardiac assistance by extracorporeal circulation called ECLS (Extra -corporeal Life support). Diaphragmatic dysfunction in intensive care has been described during prolonged stay in intensive care and early sepsis. It is associated with dyspnea and delayed weaning from mechanical ventilation. The atrophy of the diaphragm muscle is related to both loss of function and also loss of muscle performance.

Decreases in heart muscle and diaphragm performance may require both cardiac and respiratory assistance. Cardiac and respiratory dysfunctions can complicate the weaning of the respiratory assistance and also extracorporeal circulatory support supports. These two supports, respiratory and circulatory assistance, allow the purification of CO2 and respiratory assistance is known to influence the diaphragmatic function. The role of the muscular pump function in the withdrawal process of the ECLS, remains largely unknown. The aim of our study is to give a description of the physiology of the diaphragm in case of cardiogenic shock: we want to evaluate the force of the diaphragm according to the ventilation under ECLS. No studies have yet evaluated the influence of ECLS as a CO2 purification system on the performance of the diaphragm muscle.

Ultrasound is used in the patient's bed in daily practice to measure cardiac function, vessel study and diaphragm muscle. This method is reproducible and non-invasive. It can be hypothesized that there is a muscular involvement of the diaphragm under extracorporeal membrane oxygenation (ECMO) measurable by ultrasound method. Our main hypothesis is that the diaphragm force evolves according to the cleaning of the CO2 by the ECLS during the weaning of this one.

This is a Monocentric Prospective Observational Descriptive study. The objective of this study is to evaluate prospectively and consecutively the evolution of diaphragmatic muscle stress in cardiogenic shock with ultrasounds during the first ECMO weaning in intensive care patients.

When cardiogenic shock occurs, during the first ECLS weaning, we also will evaluate prospectively :

• The evolution of diaphragm muscle thickness
• The evolution of the function of the diaphragm muscle We will evaluate the impact of different risk factors on the diaphragmatic function: respiratory variables, parameters and duration of mechanical ventilation, ECLS parameters and duration, number and type of associated organ failure, gasometric variables, hemodynamic variables, presence of a cardiotomy.

And we also will evaluate the impact of the diaphragmatic function on the patient's future:

• Failure to wean from mechanical ventilation
• ECLS weaning failure
• Death in intensive care
• Length of stay in intensive care Patients will be informed and consents will be collected during hospitalization in intensive care.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38043
    • Chu Grenoble Alpes

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of diaphragm muscle thickness	The thickness of the muscle will be measured when weaning the ECMO at the same scanning levels as before (mm).	at 15 min
Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of the function of the diaphragm muscle	The function of the muscle will be measured when weaning the ECMO at the same scanning levels as before (%).	at 15 min
Evaluate the impact of different risk factors on the diaphragmatic function	Risk factors will be collected to estimate the impact on the 3 indicators of the diaphragm function (performance, thickness and function).	previous exposure before inclusion
Evaluate the impact of the diaphragmatic function on the patient's future: failure to wean from mechanical ventilation	Rate of weaning failure with mechanical ventilation will be collected	at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: ECLS weaning failure	Rate of weaning failure with ECLS will be collected	at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: Death in intensive care	Rate of mortality in intensive care will be collected.	at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: Length of stay in intensive care	Length of stay in intensive care will be collected.	at 60 days

Collaborators and Investigators

• Sponsor: Association Pro-arte
• Investigators: Principal Investigator: Pierre-Henri Moury, Chu Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ECMO; Ultrasonography; Intensive Care Units; Shock, Cardiogenic; Ventilator Weaning; Diaphragm
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: 3-2018-DIAGECMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: futur participation in respiratory protocols may include our datas.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No