Patient Dyspnea Under Veno-arterial Extracorporeal Circulation (DYSCO2)

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.

Study Overview

• Status: Completed
• Conditions: Dyspnea
• Intervention / Treatment: Other: increment sweep gas flow; Other: non-invasive ventilation

Detailed Description

Half of the patients undergoing mechanical ventilation in intensive care have moderate to severe dyspnea. This dyspnea has a negative impact on the prognosis and quality of life in the medium term.

As ECMOs, techniques for extracorporeal assistance to supplement cardiac and pulmonary functions, are developing rapidly, it seems essential to study the dyspnea associated with the use of these techniques. In particular, understanding the main mechanisms involved in the genesis of dyspnea in patients under ECMO would allow the development of therapeutic solutions aimed at minimizing it.

The investigators hypothesize that, in patients under veno-arterial ECMO with dyspnea, the dyspnea decreases in response to an increase in ECMO sweep gas flow through the membrane lung via modulation of central and peripheral chemoreceptors sensitive to variations in PaO2, PaCO2 and pH. Since dyspnea experienced by patients on veno-arterial ECMO is related to cardiogenic pulmonary edema, increased discharge from the left cavities by increasing positive expiratory pressure should also alleviate dyspnea.

The main objective of the present study is to evaluate the impact of sweep gas flow through the membrane lung and PEP incrementation on dyspnea in patients with veno-arterial ECMO with dyspnea.

Relief of dyspnea will be carried out by the clinician in charge of the patient. He will have complete control of his behaviour. He will carry out this test according to the practices in force in the department.

One of the investigators will be present and will collect the data listed above. This investigator will not intervene in the conduct of the test.

Each patient will participate in a dyspnea relief test according to the protocol of the department and according to the management of the practitioner in charge of the patient.

Initially a recording of 5 minutes will be made in the basal state, before any therapeutic action.

If a sweep gas flow through the membrane lung increment has been decided upon to relieve dyspnea, a new recording will be made after each scan increment and the patient will be asked at each step.

In ventilated or non-ventilated patients in whom the decision to implement non-invasive ventilation has been made, an increase in PEEP in 2 cmH2O steps without exceeding a plateau pressure of 25 cmH2O and a VT of 10ml/kg of the patient's theoretical weight will be achieved.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• France
  • Paris, France, 75011
    • Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

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 under veno-arterial ECMO with dyspnea

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient dyspnea under veno-arterial extracorporeal circulation; Relief of dyspnea will be carried out by the clinician in charge of the patient. He will have complete control of his behaviour. He will carry out this test according to the practices in force in the department. If a sweep gas flow through the membrane lung increment has been decided upon to relieve dyspnea, a new recording will be made after each scan increment and the patient will be asked at each step. In ventilated or non-ventilated patients in whom the decision to implement non-invasive ventilation has been made, an increase in PEEP in 2 cmH2O steps without exceeding a plateau pressure of 25 cmH2O and a VT of 10ml/kg of the patient's theoretical weight will be achieved.

Other: increment sweep gas flow; If a sweep gas flow through the membrane lung increment has been decided upon to relieve dyspnea, a new recording will be made after each scan increment and the patient will be asked at each step.; Other: non-invasive ventilation; In ventilated or non-ventilated patients in whom the decision to implement non-invasive ventilation has been made, an increase in PEEP in 2 cmH2O steps without exceeding a plateau pressure of 25 cmH2O and a VT of 10ml/kg of the patient's theoretical weight will be achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Ω. 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
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

Collaborators and Investigators

• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Investigators: Principal Investigator: Alexandre Demoule, MD, PhD, Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Electromyogram; Mechanical ventilation; Patient-ventilator interaction; Inspiratory muscles; Veno-arterial extracorporeal circulation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: 2020-A00539-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No