DyspneaDYSCO2NCT04815330
Patient Dyspnea Under Veno-arterial Extracorporeal Circulation
An observational study of Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- increment sweep gas flow and non-invasive ventilation
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2020to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under veno-arterial ECMO with dyspnea
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière
Paris, 75011
About this study
Official 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 :
Read more
- 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.
- 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.
Read the 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.
- Conditions
- Dyspnea
- Being tested
- increment sweep gas flow, non-invasive ventilation
- Keywords
- Patient-ventilator interaction, Veno-arterial extracorporeal circulation, Inspiratory muscles, Electromyogram, Mechanical ventilation
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increment sweep gas flowOther
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.
non-invasive ventilationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: increment sweep gas flow; Other: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Baseline, during the intervention
Secondary outcomes (3)
Arterial Blood Gas
If an arterial blood gas measurement is performed at the clinician's request, the results will be collated.
Measured: 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.
Measured: 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").
Measured: Baseline, during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start23 Jun 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Demoule, MD, PhD, Principal investigator, Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815330
- Sponsor's protocol ID
- 2020-A00539-30
- Acronym
- DYSCO2
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04815330
- Acronym / sponsor ID
- DYSCO2 / 2020-A00539-30
- Conditions
- Dyspnea
- Keywords
- Patient-ventilator interaction, Veno-arterial extracorporeal circulation, Inspiratory muscles, Electromyogram, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient dyspnea under veno-arterial extracorporeal circulation | – | Other: increment sweep gas flow, Other: non-invasive ventilationRelief 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under veno-arterial ECMO with dyspnea
Key inclusion criteria (8 listed)
- 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; :
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| increment sweep gas flowIf 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 | Patient dyspnea under veno-arterial extracorporeal circulation |
| non-invasive ventilationIn 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 | Patient dyspnea under veno-arterial extracorporeal circulation |
Primary outcome
Dyspnea change
Time frame: Baseline, during the intervention
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;
3 secondary outcomes
Arterial Blood Gas
Time frame: Baseline, during the intervention
Electromyogram (EMG) of extra-diaphragmatic inspiratory muscles
Time frame: Baseline, during the intervention
Evaluation of pain
Time frame: Baseline, during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Demoule, MD, PhD principal investigator
Groupe Hospitalier Universitaire APHP - Sorbonne Université Site Pitié-Salpêtrière (bâtiment Eole)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea change (time frame: Baseline, during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.