Dyspnea Clinical Trial
— DYSCO2Official title:
Patient Dyspnea Under Veno-arterial Extracorporeal Circulation: Quality, Mechanisms and Sensitivity to Increased Sweep Gas Flow Through the Membrane Lung and Positive Expiratory Pressure
Rationale: Patients with severe heart failure increasingly benefit from extracorporeal circulatory assistance (Extracorporeal Membrane Oxygenation - ECMO) that completely replaces the function of the heart and is in addition to mechanical ventilation (veno-arterial ECMO). In clinical practice, some of these patients have been found to be dyspneic, although circulatory assistance ensures satisfactory hematosis. Indeed, nearly half of the patients undergoing mechanical ventilation in intensive care have a generally intense dyspnea. In addition to the immediate discomfort caused by dyspnea, which can be assimilated to pain, this symptom is associated with a prolonged duration of mechanical ventilation and contributes to the genesis of neuropsychological sequelae of resuscitation such as post-traumatic stress syndrome. Objectives : 1. To study the effectiveness and impact of an increase in ECMO sweep gas flow through the membrane lung or positive tele-expiratory pressure (PEP) on dyspnea in patients under ECMO. 2. To understand the mechanism involved in this relief of dyspnea. Methods: in 30 patients of Intensive Care Unit, dyspnea will be evaluated by psychophysiological scales and scores as well as by neurophysiological tools (electromyography of inspiratory muscles) during sweep gas flow through the membrane lung incrementation and PEP increase. Ethical framework: Changes in ventilation parameters and ECMO will be performed in the usual manner, without additional or unusual diagnostic, treatment or monitoring procedures. Expected results and outlook: the investigators hypothesize that half of the patients on veno-arterial ECMO have dyspnea related to pulmonary edema. Therefore, an increase in PEP would alleviate this dyspnea. The investigators hypothesize that by using a relief method related to increased sweep gas flow through the membrane lung, the investigators can reduce the discomfort without inducing any associated complication. This study will improve the knowledge of the mechanisms determining dyspnea in patients under ECMO and the principle of therapeutic strategy to improve it.
Status | Completed |
Enrollment | 19 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Circulatory support by veno-arterial ECMO for cardiogenic shock; - Presence of severe respiratory distress; - Presence of dyspnea = 40 mm on a visual analogue scale of dyspnea (VAS-dyspnea) - Decision by the clinician in charge of the patient to either modify the ECMO parameters or to administer non-invasive ventilation in order to decrease the intensity of the dyspnea; - presence of an arterial catheter; : - RASS score between 0 and +1 ; - Absence of delirium on the CAM-ICU score; - being socially insured. Exclusion Criteria: - patient unable to express opposition; - protected minor or adult patient; - pregnant woman; - double veno-arterial ECMO; central ECMO; left ventricular assist or long-term bi-ventricular assist |
Country | Name | City | State |
---|---|---|---|
France | Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dyspnea change | A quantification of dyspnea will be carried out by visual analogue dyspnea scale (D-VAS). This scale with a cursor will be presented vertically to the patient at inclusion, then at the end of each period and will be graduated from 0 (no dyspnea) to 100 (maximum dyspnea). The patient will indicate the intensity of the dyspnea with a slider; | Baseline, during the intervention | |
Secondary | Arterial Blood Gas | If an arterial blood gas measurement is performed at the clinician's request, the results will be collated. | Baseline, during the intervention | |
Secondary | Electromyogram (EMG) of extra-diaphragmatic inspiratory muscles | The amplitude of the EMG signal of the extra-diaphragmatic inspiratory muscles is proportional to the intensity of the dyspnea. The EMG will be collected by self-adhesive surface electrodes of the same type as those usually used to collect the ECG signal in ICU patients. A distance of 2 cm will separate the two electrodes. The impedance should be less than 2000 O. The position of the electrodes will depend on the muscle whose EMG activity is being collected: parasternal intercostal muscles: opposite the 2nd intercostal space, as close as possible to the sternum; Alae nasi muscles: on the wings of the nose. |
Baseline, during the intervention | |
Secondary | Evaluation of pain | Pain: Pain will be assessed using a visual analog scale ranging from 0 ("no pain") to 100 ("maximum pain"). | Baseline, during the intervention |
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