Patient Dyspnea Under Veno-arterial Extracorporeal Circulation

NCT04815330 | Completed

• 1 other identifier: 2020-A00539-30
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Dyspnea

Keywords

Patient-ventilator interaction; Veno-arterial extracorporeal circulation; Inspiratory muscles; Electromyogram; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Arterial Blood Gas

  Baseline, during the intervention

• Electromyogram (EMG) of extra-diaphragmatic inspiratory muscles

  Baseline, during the intervention

• Evaluation of pain

  Baseline, during the intervention

Study Arms (1)

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; Other: non-invasive ventilation

Interventions

increment sweep gas flow OTHER

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.

Patient dyspnea under veno-arterial extracorporeal circulation

non-invasive ventilation OTHER

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.

Patient dyspnea under veno-arterial extracorporeal circulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients under veno-arterial ECMO with dyspnea

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil: lead

Study Sites (1)

Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

Paris, 75011, France

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Alexandre Demoule, MD, PhD

  Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 25, 2021
• Study Start: June 23, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)