DiaphragmATROPHY-ECMONCT04052230
Evolution of Diaphragm Thickness Under Veno-arterial ECMO
An observational study of Diaphragm and Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients. The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ultrasound measure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2019to 19 Apr 2022
- 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: The study population is adult patients hospitalized in intensive care for circulatory insufficiency requiring assistance with ECMO VA.
Who may be able to join
- Patient hospitalized in intensive care
- Patient under veno-arterial ECMO
- Non-opposition of the patient or relatives
- Affiliation to a health insurance
Who cannot join
- Subject under guardianship or subject deprived of liberty
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Diaphragm Thickness Under Veno-arterial ECMO : Observational Study
The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients.
The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the deterioration of patients' prognosis.
Read the detailed description
The evolution of diaphragm muscle thickness is described in human resuscitation under mechanical ventilation, but the incidence, causes and functional impact have not been studied in patients undergoing cardiopulmonary bypass ECMO (extra-corporeal membrane oxygenation) veno-arterial (VA). More generally, the muscular mechanisms of dyspnea in cases of acute cardiac dysfunction are not known.
The evolution of the diaphragmatic thickness in intensive care has been described during prolonged stay in intensive care and from the initial phase of septic status. It is associated with dyspnea, weaning delay of mechanical ventilation and impact on patient outcomes. The atrophy of the diaphragm muscle is related to both loss of function and loss of muscle performance. The same is true for hypertrophy that is caused by overuse of the muscle and also causes loss of function.
Decreased cardiac muscle performance may require both cardiac assistance and respiratory assistance. Cardiac and respiratory dysfunction may complicate withdrawal of respiratory assistance and extracorporeal circulatory support devices. These two supports, respiratory and circulatory support, make it possible to mitigate the insufficiency of the systemic flow, the oxygenation and the purification of the CO2. Respiratory assistance is known to influence the diaphragmatic function. The role of muscle pump function in the weaning process of the ECMO, however, remains largely unknown.
Ultrasound is used in the patient's bed in daily practice to measure cardiac function, the study of vessels but also the diaphragm muscle. It allows to study the trophicity of the diaphragm and these efforts via its contraction. The hypothesis that there is muscular involvement of the diaphragm in this measurable condition by ultrasound method can be formulated.
No study has systematically explored the existence of diaphragmatic atrophy under VA ECMO. The influence of cardiac and respiratory assistance is not known.
The purpose of this study is to provide a description of the diaphragm physiology of patients treated with VA ECMO.
It is to evaluate the evolution of the trophicity of the diaphragm muscle in intensive care.
Secondly, to evaluate the factors that influence it at the time of weaning. In this study it's planed to include a cohort of patients with a longitudinal evaluation of the thickness of the diaphragm during a cardiogenic shock under ECMO, and an evaluation of the influence of ECMO parameters and ventilation on the diaphragm.
- Being tested
- ultrasound measure
- Keywords
- diaphragm, ECMO, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measureOther
Admission to the intensive care unit, and setting up an ECMO Daily monitoring from D1 to D7, follow up at D60
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care.
Evaluation of the trophicity of the diaphragm muscle at the end of the expiration from the first day in the intensive care unit after the ECMO implementation until the D7 of the hospitalization with ultrasound. A change greater than 10% of the thickness will define three groups of patients (loss of thickness, stability and thickness gain). The first day that this value is reached will determine the allocation in one or the other group.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Secondary outcomes (27)
To evaluate the evolution of the performance of the diaphragm muscle in patients in intensive care.
Measurement of the thickening fraction of the diaphragm.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Measurement of the daily evolution of tidal volume during ultrasound collection
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Measurement of the daily evolution of respiratory rate during ultrasound collection
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Measurement of the daily evolution of pulse oximetry during ultrasound collection
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Measurement of the daily evolution of occlusion pressure at 100ms (P0.1)during ultrasound collection
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Measurement of the daily evolution of maximum inspiratory pressure (MIP) during ultrasound collection
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Measurement of the daily evolution of SNIFF test during ultrasound collection
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily ventilatory mode
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily tidal volume
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily respiratory rate
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily positive expiratory pressure
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily plateau pressure
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily motor pressure
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily transpulmonary pressure
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily oesophageal pressure
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Measurement of the daily O2 inspired fraction.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Measurement of the daily the daily blood flow
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Measurement of the daily the daily sweep rate
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Measurement of the daily the daily oxygenation
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Measurement of the daily percentage of the theoretical flow
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Measurement of the daily duration of ECMO
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Measurement of the daily the success of weaning.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the associated organ failures and the diaphragm evolution in patients in intensive care
The daily change in the incidence of diaphragmatic dysfunction defined by the diaphragm thickening fraction <20% during a maximal inspiratory test to J7. The daily collection of hemodynamic variables during the diaphragmatic ultrasound collection including an evaluation of the visual LVEF.
Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Measurement of the survival
Measured: Day 60
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Measurement of the length of stay in intensive care unit
Measured: Day 60
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Measurement of the failure of extubation
Measured: Day 60
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Measurement of the number of days without mechanical ventilation
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start13 Oct 2019
- Primary completion18 Feb 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiaphragmStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052230
- Sponsor's protocol ID
- 38RC19.142
- Other IDs
- 2019-A01273-54
- Acronym
- ATROPHY-ECMO
- Status last verified
- May 2023
- First submitted
- 11 Jun 2019
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Diaphragm Thickness Under Veno-arterial ECMO : Observational Study
- ClinicalTrials.gov ID
- NCT04052230
- Acronym / sponsor ID
- ATROPHY-ECMO / 38RC19.142
- Keywords
- diaphragm, ECMO, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 9 Aug 2019 (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.
The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients.
The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the deterioration of patients' prognosis.
Detailed description
The evolution of diaphragm muscle thickness is described in human resuscitation under mechanical ventilation, but the incidence, causes and functional impact have not been studied in patients undergoing cardiopulmonary bypass ECMO (extra-corporeal membrane oxygenation) veno-arterial (VA). More generally, the muscular mechanisms of dyspnea in cases of acute cardiac dysfunction are not known.
The evolution of the diaphragmatic thickness in intensive care has been described during prolonged stay in intensive care and from the initial phase of septic status. It is associated with dyspnea, weaning delay of mechanical ventilation and impact on patient outcomes. The atrophy of the diaphragm muscle is related to both loss of function and loss of muscle performance. The same is true for hypertrophy that is caused by overuse of the muscle and also causes loss of function.
Decreased cardiac muscle performance may require both cardiac assistance and respiratory assistance. Cardiac and respiratory dysfunction may complicate withdrawal of respiratory assistance and extracorporeal circulatory support devices. These two supports, respiratory and circulatory support, make it possible to mitigate the insufficiency of the systemic flow, the oxygenation and the purification of the CO2. Respiratory assistance is known to influence the diaphragmatic function. The role of muscle pump function in the weaning process of the ECMO, however, remains largely unknown.
Ultrasound is used in the patient's bed in daily practice to measure cardiac function, the study of vessels but also the diaphragm muscle. It allows to study the trophicity of the diaphragm and these efforts via its contraction. The hypothesis that there is muscular involvement of the diaphragm in this measurable condition by ultrasound method can be formulated.
No study has systematically explored the existence of diaphragmatic atrophy under VA ECMO. The influence of cardiac and respiratory assistance is not known.
The purpose of this study is to provide a description of the diaphragm physiology of patients treated with VA ECMO.
It is to evaluate the evolution of the trophicity of the diaphragm muscle in intensive care.
Secondly, to evaluate the factors that influence it at the time of weaning. In this study it's planed to include a cohort of patients with a longitudinal evaluation of the thickness of the diaphragm during a cardiogenic shock under ECMO, and an evaluation of the influence of ECMO parameters and ventilation on the diaphragm.
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
- The study population is adult patients hospitalized in intensive care for circulatory insufficiency requiring assistance with ECMO VA.
Key inclusion criteria (4 listed)
- Patient hospitalized in intensive care
- Patient under veno-arterial ECMO
- Non-opposition of the patient or relatives
- Affiliation to a health insurance
Key exclusion criteria (2 listed)
- Subject under guardianship or subject deprived of liberty
- Pregnant or lactating woman
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 |
|---|---|---|
| ultrasound measureAdmission to the intensive care unit, and setting up an ECMO Daily monitoring from D1 to D7, follow up at D60 | Other | – |
Primary outcome
To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
Evaluation of the trophicity of the diaphragm muscle at the end of the expiration from the first day in the intensive care unit after the ECMO implementation until the D7 of the hospitalization with ultrasound. A change greater than 10% of the thickness will define three groups of patients (loss of thickness, stability and thickness gain). The first day that this value is reached will determine the allocation in one or the other group.
27 secondary outcomes
To evaluate the evolution of the performance of the diaphragm muscle in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between parameters of mechanical ventilation and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the impact of ECMO parameters and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the link between the associated organ failures and the diaphragm evolution in patients in intensive care
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Time frame: Day 60
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Time frame: Day 60
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Time frame: Day 60
To evaluate the impact of the diaphragm evolution on the future of the patient in intensive care: weaning of the assistances, survivals.and the diaphragm
Time frame: Day 60
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 12 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diaphragm and Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Grenoble 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 2 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 12 May 2023. 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?
To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care. (time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7). 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 12 May 2023.