Cardiogenic ShockDIAG-ECMONCT03736239
Ultrasound Study of the Diaphragm Evolution Under ECMO
An observational study of Cardiogenic Shock and Weaning Failure, run by Association Pro-arte at 1 site in France.
Trial summary
Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Weaning Failure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2018to 5 Jun 2019
- 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 will be recruited into the intensive care unit of the investigating center, under the responsibility of the principal investigator of the study. All patients admitted to intensive care present cardiogenic shock. After verification of the inclusion and non-inclusion criteria, the information on the diagnostic procedures will be given by one of the investigators. Due to the observational nature of the research, patients can participate in another one. There is not an exclusion period at the end of the search.
Who may be able to join
- Patient hospitalized in intensive care for cardiogenic shock under ECMO (extracorporeal membrane oxygenator)
- Veno-arterial ECMO
- ECMO withdrawal decision
- Patient or family agreeing to participate in research
Who cannot join
- Patient under guardianship or curatorship
- Contraindication to spontaneous ventilation
- Pregnant woman
- Anechoic patient for diaphragmatic ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients.
Read the detailed description
Diaphragmatic atrophy and diaphragmatic dysfunction are described in human resuscitation under mechanical ventilation, but this diaphragmatic function has not been studied in patients with cardiogenic shock and also under cardiac assistance by extracorporeal circulation called ECLS (Extra -corporeal Life support). Diaphragmatic dysfunction in intensive care has been described during prolonged stay in intensive care and early sepsis. It is associated with dyspnea and delayed weaning from mechanical ventilation. The atrophy of the diaphragm muscle is related to both loss of function and also loss of muscle performance.
Decreases in heart muscle and diaphragm performance may require both cardiac and respiratory assistance. Cardiac and respiratory dysfunctions can complicate the weaning of the respiratory assistance and also extracorporeal circulatory support supports. These two supports, respiratory and circulatory assistance, allow the purification of CO2 and respiratory assistance is known to influence the diaphragmatic function. The role of the muscular pump function in the withdrawal process of the ECLS, remains largely unknown. The aim of our study is to give a description of the physiology of the diaphragm in case of cardiogenic shock: we want to evaluate the force of the diaphragm according to the ventilation under ECLS. No studies have yet evaluated the influence of ECLS as a CO2 purification system on the performance of the diaphragm muscle.
Ultrasound is used in the patient's bed in daily practice to measure cardiac function, vessel study and diaphragm muscle. This method is reproducible and non-invasive. It can be hypothesized that there is a muscular involvement of the diaphragm under extracorporeal membrane oxygenation (ECMO) measurable by ultrasound method. Our main hypothesis is that the diaphragm force evolves according to the cleaning of the CO2 by the ECLS during the weaning of this one.
This is a Monocentric Prospective Observational Descriptive study. The objective of this study is to evaluate prospectively and consecutively the evolution of diaphragmatic muscle stress in cardiogenic shock with ultrasounds during the first ECMO weaning in intensive care patients.
When cardiogenic shock occurs, during the first ECLS weaning, we also will evaluate prospectively :
- The evolution of diaphragm muscle thickness
- The evolution of the function of the diaphragm muscle We will evaluate the impact of different risk factors on the diaphragmatic function: respiratory variables, parameters and duration of mechanical ventilation, ECLS parameters and duration, number and type of associated organ failure, gasometric variables, hemodynamic variables, presence of a cardiotomy.
And we also will evaluate the impact of the diaphragmatic function on the patient's future:
- Failure to wean from mechanical ventilation
- ECLS weaning failure
- Death in intensive care
- Length of stay in intensive care Patients will be informed and consents will be collected during hospitalization in intensive care.
- Conditions
- Cardiogenic Shock, Weaning Failure
- Keywords
- ECMO, Intensive Care Units, Shock, Cardiogenic, Ventilator Weaning, Diaphragm, Ultrasonography
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the evolution of the diaphragm muscle effort in cardiogenic shock during the first ECLS weaning in patients in ICU.
The performance of the diaphragm muscle will be evaluated by ultrasonography (the thickening fraction of the diaphragm) during the weaning of the ECMO at different weaning level : after 15 minutes (Baseline, 4 l/min, 2 l / min, 1 l / min). Wash out of 10 min between each measurement. The parameters of the assisted ventilation will be standardized according to the practices of the service and recommendations.
Measured: at 15 min
Secondary outcomes (7)
Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of diaphragm muscle thickness
The thickness of the muscle will be measured when weaning the ECMO at the same scanning levels as before (mm).
Measured: at 15 min
Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of the function of the diaphragm muscle
The function of the muscle will be measured when weaning the ECMO at the same scanning levels as before (%).
Measured: at 15 min
Evaluate the impact of different risk factors on the diaphragmatic function
Risk factors will be collected to estimate the impact on the 3 indicators of the diaphragm function (performance, thickness and function).
Measured: previous exposure before inclusion
Evaluate the impact of the diaphragmatic function on the patient's future: failure to wean from mechanical ventilation
Rate of weaning failure with mechanical ventilation will be collected
Measured: at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: ECLS weaning failure
Rate of weaning failure with ECLS will be collected
Measured: at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: Death in intensive care
Rate of mortality in intensive care will be collected.
Measured: at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: Length of stay in intensive care
Length of stay in intensive care will be collected.
Measured: at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start15 Jun 2018
- Primary completion3 Apr 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pro-arte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Henri Moury, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736239
- Sponsor's protocol ID
- 3-2018-DIAGECMO
- Acronym
- DIAG-ECMO
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: futur participation in respiratory protocols may include our datas.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Study of the Diaphragm Evolution Under ECMO
- ClinicalTrials.gov ID
- NCT03736239
- Acronym / sponsor ID
- DIAG-ECMO / 3-2018-DIAGECMO
- Conditions
- Cardiogenic Shock, Weaning Failure
- Keywords
- ECMO, Intensive Care Units, Shock, Cardiogenic, Ventilator Weaning, Diaphragm, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Association Pro-arteUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 9 Nov 2018 (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.
Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients.
Detailed description
Diaphragmatic atrophy and diaphragmatic dysfunction are described in human resuscitation under mechanical ventilation, but this diaphragmatic function has not been studied in patients with cardiogenic shock and also under cardiac assistance by extracorporeal circulation called ECLS (Extra -corporeal Life support). Diaphragmatic dysfunction in intensive care has been described during prolonged stay in intensive care and early sepsis. It is associated with dyspnea and delayed weaning from mechanical ventilation. The atrophy of the diaphragm muscle is related to both loss of function and also loss of muscle performance.
Decreases in heart muscle and diaphragm performance may require both cardiac and respiratory assistance. Cardiac and respiratory dysfunctions can complicate the weaning of the respiratory assistance and also extracorporeal circulatory support supports. These two supports, respiratory and circulatory assistance, allow the purification of CO2 and respiratory assistance is known to influence the diaphragmatic function. The role of the muscular pump function in the withdrawal process of the ECLS, remains largely unknown. The aim of our study is to give a description of the physiology of the diaphragm in case of cardiogenic shock: we want to evaluate the force of the diaphragm according to the ventilation under ECLS. No studies have yet evaluated the influence of ECLS as a CO2 purification system on the performance of the diaphragm muscle.
Ultrasound is used in the patient's bed in daily practice to measure cardiac function, vessel study and diaphragm muscle. This method is reproducible and non-invasive. It can be hypothesized that there is a muscular involvement of the diaphragm under extracorporeal membrane oxygenation (ECMO) measurable by ultrasound method. Our main hypothesis is that the diaphragm force evolves according to the cleaning of the CO2 by the ECLS during the weaning of this one.
This is a Monocentric Prospective Observational Descriptive study. The objective of this study is to evaluate prospectively and consecutively the evolution of diaphragmatic muscle stress in cardiogenic shock with ultrasounds during the first ECMO weaning in intensive care patients.
When cardiogenic shock occurs, during the first ECLS weaning, we also will evaluate prospectively :
- The evolution of diaphragm muscle thickness
- The evolution of the function of the diaphragm muscle We will evaluate the impact of different risk factors on the diaphragmatic function: respiratory variables, parameters and duration of mechanical ventilation, ECLS parameters and duration, number and type of associated organ failure, gasometric variables, hemodynamic variables, presence of a cardiotomy.
And we also will evaluate the impact of the diaphragmatic function on the patient's future:
- Failure to wean from mechanical ventilation
- ECLS weaning failure
- Death in intensive care
- Length of stay in intensive care Patients will be informed and consents will be collected during hospitalization in intensive care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited into the intensive care unit of the investigating center, under the responsibility of the principal investigator of the study. All patients admitted to intensive care present cardiogenic shock. After verification of the inclusion and non-inclusion criteria, the information on the diagnostic procedures will be given by one of the investigators. Due to the observational nature of the research, patients can participate in another one. There is not an exclusion period at the end of the search.
Key inclusion criteria (4 listed)
- Patient hospitalized in intensive care for cardiogenic shock under ECMO (extracorporeal membrane oxygenator)
- Veno-arterial ECMO
- ECMO withdrawal decision
- Patient or family agreeing to participate in research
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Contraindication to spontaneous ventilation
- Pregnant woman
- Anechoic patient for diaphragmatic ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the evolution of the diaphragm muscle effort in cardiogenic shock during the first ECLS weaning in patients in ICU.
Time frame: at 15 min
The performance of the diaphragm muscle will be evaluated by ultrasonography (the thickening fraction of the diaphragm) during the weaning of the ECMO at different weaning level : after 15 minutes (Baseline, 4 l/min, 2 l / min, 1 l / min). Wash out of 10 min between each measurement. The parameters of the assisted ventilation will be standardized according to the practices of the service and recommendations.
7 secondary outcomes
Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of diaphragm muscle thickness
Time frame: at 15 min
Evaluate prospectively during cardiogenic shock when weaning from ECLS, the evolution of the function of the diaphragm muscle
Time frame: at 15 min
Evaluate the impact of different risk factors on the diaphragmatic function
Time frame: previous exposure before inclusion
Evaluate the impact of the diaphragmatic function on the patient's future: failure to wean from mechanical ventilation
Time frame: at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: ECLS weaning failure
Time frame: at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: Death in intensive care
Time frame: at 60 days
Evaluate the impact of the diaphragmatic function on the patient's future: Length of stay in intensive care
Time frame: at 60 days
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 14 Jun 2019.
- Individual participant dataSharing planned: Undecided. futur participation in respiratory protocols may include our datas.
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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.
Pierre-Henri Moury principal investigator
CHU Grenoble Alpes
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 Cardiogenic Shock and Weaning Failure, run by Association Pro-arte 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 4 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 14 Jun 2019. 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?
Evaluate the evolution of the diaphragm muscle effort in cardiogenic shock during the first ECLS weaning in patients in ICU. (time frame: at 15 min). 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 14 Jun 2019.