Evolution of Diaphragm Thickness Under Veno-arterial ECMO

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— ATROPHY-ECMO  

Official title:

Evolution of Diaphragm Thickness Under Veno-arterial ECMO : Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052230
• Other study ID #: 38RC19.142
• Secondary ID: 2019-A01273-54
• Status: Completed
• Start date: October 13, 2019
• Est. completion date: April 19, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients.

The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the deterioration of patients' prognosis.

Description:

The evolution of diaphragm muscle thickness is described in human resuscitation under mechanical ventilation, but the incidence, causes and functional impact have not been studied in patients undergoing cardiopulmonary bypass ECMO (extra-corporeal membrane oxygenation) veno-arterial (VA). More generally, the muscular mechanisms of dyspnea in cases of acute cardiac dysfunction are not known.

The evolution of the diaphragmatic thickness in intensive care has been described during prolonged stay in intensive care and from the initial phase of septic status. It is associated with dyspnea, weaning delay of mechanical ventilation and impact on patient outcomes. The atrophy of the diaphragm muscle is related to both loss of function and loss of muscle performance. The same is true for hypertrophy that is caused by overuse of the muscle and also causes loss of function.

Decreased cardiac muscle performance may require both cardiac assistance and respiratory assistance. Cardiac and respiratory dysfunction may complicate withdrawal of respiratory assistance and extracorporeal circulatory support devices. These two supports, respiratory and circulatory support, make it possible to mitigate the insufficiency of the systemic flow, the oxygenation and the purification of the CO2. Respiratory assistance is known to influence the diaphragmatic function. The role of muscle pump function in the weaning process of the ECMO, however, remains largely unknown.

Ultrasound is used in the patient's bed in daily practice to measure cardiac function, the study of vessels but also the diaphragm muscle. It allows to study the trophicity of the diaphragm and these efforts via its contraction. The hypothesis that there is muscular involvement of the diaphragm in this measurable condition by ultrasound method can be formulated.

No study has systematically explored the existence of diaphragmatic atrophy under VA ECMO. The influence of cardiac and respiratory assistance is not known.

The purpose of this study is to provide a description of the diaphragm physiology of patients treated with VA ECMO.

It is to evaluate the evolution of the trophicity of the diaphragm muscle in intensive care.

Secondly, to evaluate the factors that influence it at the time of weaning. In this study it's planed to include a cohort of patients with a longitudinal evaluation of the thickness of the diaphragm during a cardiogenic shock under ECMO, and an evaluation of the influence of ECMO parameters and ventilation on the diaphragm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 19, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient hospitalized in intensive care

• Patient under veno-arterial ECMO

• Non-opposition of the patient or relatives

• Affiliation to a health insurance

Exclusion Criteria:

• Subject under guardianship or subject deprived of liberty

• Pregnant or lactating woman

Related Conditions & MeSH terms

• Diaphragm
• Extracorporeal Membrane Oxygenation Complication

Intervention

Other:
• ultrasound measure
Admission to the intensive care unit, and setting up an ECMO Daily monitoring from D1 to D7, follow up at D60

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care.	Evaluation of the trophicity of the diaphragm muscle at the end of the expiration from the first day in the intensive care unit after the ECMO implementation until the D7 of the hospitalization with ultrasound. A change greater than 10% of the thickness will define three groups of patients (loss of thickness, stability and thickness gain). The first day that this value is reached will determine the allocation in one or the other group.	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the evolution of the performance of the diaphragm muscle in patients in intensive care.	Measurement of the thickening fraction of the diaphragm.	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.	Measurement of the daily evolution of tidal volume during ultrasound collection	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.	Measurement of the daily evolution of respiratory rate during ultrasound collection	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.	Measurement of the daily evolution of pulse oximetry during ultrasound collection	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.	Measurement of the daily evolution of occlusion pressure at 100ms (P0.1)during ultrasound collection	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.	Measurement of the daily evolution of maximum inspiratory pressure (MIP) during ultrasound collection	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.	Measurement of the daily evolution of SNIFF test during ultrasound collection	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily ventilatory mode	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily tidal volume	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily respiratory rate	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily positive expiratory pressure	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily plateau pressure	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily motor pressure	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily transpulmonary pressure	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily oesophageal pressure	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care	Measurement of the daily O2 inspired fraction.	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care	Measurement of the daily the daily blood flow	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care	Measurement of the daily the daily sweep rate	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care	Measurement of the daily the daily oxygenation	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care	Measurement of the daily percentage of the theoretical flow	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care	Measurement of the daily duration of ECMO	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care	Measurement of the daily the success of weaning.	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the link between the associated organ failures and the diaphragm evolution in patients in intensive care	The daily change in the incidence of diaphragmatic dysfunction defined by the diaphragm thickening fraction <20% during a maximal inspiratory test to J7. The daily collection of hemodynamic variables during the diaphragmatic ultrasound collection including an evaluation of the visual LVEF.	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary	To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm	Measurement of the survival	Day 60
Secondary	To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm	Measurement of the length of stay in intensive care unit	Day 60
Secondary	To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm	Measurement of the failure of extubation	Day 60
Secondary	To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm	Measurement of the number of days without mechanical ventilation	Day 60