An observational study in Dyspnea, sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Observational
Among 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil — 1 open to participants now, 1 under way, none of them phase 3. Dyspnea · Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil.
Among the 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil, this one is the only one that started in 2020, is one of 4 observational ones, and was the 9th registered.
894 studies on the registry are indexed under Dyspnea; 189 are open to participants now.
This study's enrollment of 19 is below the median of 106 across 272 observational studies indexed under Dyspnea.
Browse Dyspnea studies →1 of the 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil is open now, in 1 country. Each count lists the studies.
Of the 124 Dyspnea studies recruiting now, 69 (56%) set no upper age limit and 40 (32%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2020.
Median enrollment 33 across the 6 interventional studies, 20 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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 :
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.
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.
Patients under veno-arterial ECMO with dyspnea
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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;
Time frame: Baseline, during the intervention
Arterial Blood Gas
If an arterial blood gas measurement is performed at the clinician's request, the results will be collated.
Time frame: 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.
Time frame: 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").
Time frame: Baseline, during the intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Aug 2021, 14 months.
Of 116 non-industry observational studies under Dyspnea, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 14 months is below that.
Counting every sponsor, half of 125 studies reached it within 24 months; a quarter within 11 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil