Septic ShockECHODIAPHNCT02766946
Diaphragmatic Atrophy Related to Mechanical Ventilation
A study testing Ultrasound, Neuromyopathy score and Respiratory performances in people with Septic Shock and Acute Respiratory Distress, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon.
Trial summary
Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Respiratory Distress
- What is being tested?
- Ultrasound, Neuromyopathy score and Respiratory performances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2013to 22 Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years old
- Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days)
- Group 2 : under Non-invasive Ventilation
- Group 3 : Spontaneous Ventilation
- Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1)
Who cannot join
- Known diaphragmatic paralysis
- Neurologic pathology with motor deficit
- Pregnancy or breast-feeding woman
About this study
Official title: Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit
Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy.
The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit).
The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.
- Conditions
- Septic Shock, Acute Respiratory Distress
- Being tested
- Ultrasound, Neuromyopathy score, Respiratory performances
- Keywords
- Mechanical Ventilation
- Medical subject headings
- Shock, Septic, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10
UltrasoundDevice
An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10
Neuromyopathy scoreOther
A neuromyopathy score will be assessed on the extubation day
Respiratory performancesOther
An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Ventilation | Experimental | Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Mechanical Ventilation
Interventions :
* Ultrasound of the right diaphragm
* Ultrasound of the pectoral muscle
* Neuromyopathy score
* Respiratory performances Receives: Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances |
| Non-invasive Ventilation | Active comparator | Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Non-invasive Ventilation
Interventions :
* Ultrasound of the right diaphragm
* Ultrasound of the pectoral muscle
* Neuromyopathy score
* Respiratory performances Receives: Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances |
| Spontaneous Ventilation | Active comparator | Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Spontaneous Ventilation
Interventions :
* Ultrasound of the right diaphragm
* Ultrasound of the pectoral muscle
* Neuromyopathy score
* Respiratory performances Receives: Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from day 1 diaphragm thickness at day 3 and day 5
Diaphragm thickness measured by ultrasound
Measured: 1 day, 3 days and 5 days after introduction of Mechanical Ventilation
Secondary outcomes (15)
Diaphragm thickness measured by ultrasound
Measured: 10 days after introduction of Mechanical Ventilation
Type of ventilatory support
Define which type of ventilatory support is used (mechanical ventilation, non-invasive ventilation, or spontaneous ventilation)
Measured: 10 days after start of ventilatory support
Ventilatory mode
Ventilatory mode (controlled ventilation, pressure support ventilation)
Measured: 10 days after start of ventilatory support
Pectoralis muscle thickness measured by ultrasound
To compare the importance of this atrophy to those of diaphragmatic muscle
Measured: 10 days after start of ventilatory support
Diaphragmatic strength
Relation between diaphragmatic atrophy and decrease of diaphragmatic strength
Measured: intraoperative
Early or late extubation failure rate (extubation performed before or after 48 hours)
Relation between diaphragmatic atrophy importance and premature (<48h) or late extubation failure
Measured: The last day of hospitalisation
MRC score (Medical Research Council)
Relation between diaphragmatic atrophy and decrease of diaphragmatic strength
Measured: intraoperative
Length of ventilation in hours
Measured: 10 days after start of ventilatory support
Drug administration
Presence of drug administration such as curare, corticoid or sedative. If yes : number of days with treatment
Measured: 10 days after start of ventilatory support
Total positive end expiratory pressure
Measured: 10 days after start of ventilatory support
External positive end expiratory pressure
Measured: 10 days after start of ventilatory support
Respiratory rate
Measured: 10 days after start of ventilatory support
Highest inspiratory pressure level
Measured: 10 days after start of ventilatory support
Highest expiratory pressure level
Measured: 10 days after start of ventilatory support
Volume of exhaled air
Measured: 10 days after start of ventilatory support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start24 Jun 2013
- Primary completion17 Dec 2015
- Study completion22 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766946
- Sponsor's protocol ID
- SJSL12013
- Acronym
- ECHODIAPH
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2016
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02766946
- Acronym / sponsor ID
- ECHODIAPH / SJSL12013
- Conditions
- Septic Shock, Acute Respiratory Distress
- Keywords
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 24 Jun 2013 (actual)
- Primary completion
- 17 Dec 2015 (actual)
- Study completion
- 22 Dec 2015 (actual)
- First posted
- 10 May 2016 (estimated)
- 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.
Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy.
The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit).
The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilation | Experimental | Device: Ultrasound, Other: Neuromyopathy score, Other: Respiratory performancesEvolution over time of Diaphragmatic and Pectoralis muscle atrophy under Mechanical Ventilation Interventions : * Ultrasound of the right diaphragm * Ultrasound of the pectoral muscle * Neuromyopathy score * Respiratory performances |
| Non-invasive Ventilation | Active comparator | Device: Ultrasound, Other: Neuromyopathy score, Other: Respiratory performancesEvolution over time of Diaphragmatic and Pectoralis muscle atrophy under Non-invasive Ventilation Interventions : * Ultrasound of the right diaphragm * Ultrasound of the pectoral muscle * Neuromyopathy score * Respiratory performances |
| Spontaneous Ventilation | Active comparator | Device: Ultrasound, Other: Neuromyopathy score, Other: Respiratory performancesEvolution over time of Diaphragmatic and Pectoralis muscle atrophy under Spontaneous Ventilation Interventions : * Ultrasound of the right diaphragm * Ultrasound of the pectoral muscle * Neuromyopathy score * Respiratory performances |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old
- Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days)
- Group 2 : under Non-invasive Ventilation
- Group 3 : Spontaneous Ventilation
- Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1)
Key exclusion criteria (3 listed)
- Known diaphragmatic paralysis
- Neurologic pathology with motor deficit
- Pregnancy or breast-feeding 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 |
|---|---|---|
| UltrasoundAn ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10 | Device | Mechanical Ventilation, Non-invasive Ventilation, Spontaneous Ventilation |
| UltrasoundAn ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10 | Device | Mechanical Ventilation, Non-invasive Ventilation, Spontaneous Ventilation |
| Neuromyopathy scoreA neuromyopathy score will be assessed on the extubation day | Other | Mechanical Ventilation, Non-invasive Ventilation, Spontaneous Ventilation |
| Respiratory performancesAn assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure | Other | Mechanical Ventilation, Non-invasive Ventilation, Spontaneous Ventilation |
Primary outcome
Change from day 1 diaphragm thickness at day 3 and day 5
Time frame: 1 day, 3 days and 5 days after introduction of Mechanical Ventilation
Diaphragm thickness measured by ultrasound
15 secondary outcomes
Diaphragm thickness measured by ultrasound
Time frame: 10 days after introduction of Mechanical Ventilation
Type of ventilatory support
Time frame: 10 days after start of ventilatory support
Ventilatory mode
Time frame: 10 days after start of ventilatory support
Pectoralis muscle thickness measured by ultrasound
Time frame: 10 days after start of ventilatory support
Diaphragmatic strength
Time frame: intraoperative
Early or late extubation failure rate (extubation performed before or after 48 hours)
Time frame: The last day of hospitalisation
MRC score (Medical Research Council)
Time frame: intraoperative
Length of ventilation in hours
Time frame: 10 days after start of ventilatory support
Drug administration
Time frame: 10 days after start of ventilatory support
Total positive end expiratory pressure
Time frame: 10 days after start of ventilatory support
External positive end expiratory pressure
Time frame: 10 days after start of ventilatory support
Respiratory rate
Time frame: 10 days after start of ventilatory support
Highest inspiratory pressure level
Time frame: 10 days after start of ventilatory support
Highest expiratory pressure level
Time frame: 10 days after start of ventilatory support
Volume of exhaled air
Time frame: 10 days after start of ventilatory support
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 4 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Neuromyopathy score and Respiratory performances in people with Septic Shock and Acute Respiratory Distress, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon.
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 5 inclusion and 3 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from day 1 diaphragm thickness at day 3 and day 5 (time frame: 1 day, 3 days and 5 days after introduction of Mechanical Ventilation). 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 4 Apr 2024.