Ultrasound Study of the Diaphragm Evolution Under ECMO

Cardiogenic Shock Clinical Trial

— DIAG-ECMO  

Official title:

Ultrasound Study of the Diaphragm Evolution Under ECMO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736239
• Other study ID #: 3-2018-DIAGECMO
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: June 2019
• Source: Association Pro-arte
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 5, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic
• Weaning Failure

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
Association Pro-arte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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