An observational study in Diaphragm and Extracorporeal Membrane Oxygenation Complication, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by University Hospital, Grenoble · Observational
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.
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.
University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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The study population is adult patients hospitalized in intensive care for circulatory insufficiency requiring assistance with ECMO VA.
Exclusion Criteria:
Admission to the intensive care unit, and setting up an ECMO Daily monitoring from D1 to D7, follow up at D60
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.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the evolution of the performance of the diaphragm muscle in patients in intensive care.
Measurement of the thickening fraction of the diaphragm.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily ventilatory mode
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily tidal volume
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily respiratory rate
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily plateau pressure
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily motor pressure
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily transpulmonary pressure
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily oesophageal pressure
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
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
Time frame: Day 60
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
Time frame: Day 60
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
Time frame: Day 60
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
Time frame: Day 60
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble