Ventilator WeaningElasto-ICUNCT03832231
Use of Transient Elastogaphy to Assess Diaphragm Function in Mechanically Ventilated Patients
A study testing Shear Wave Elastography in people with Ventilator Weaning and Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Intensive Care Unit
- What is being tested?
- Shear Wave Elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2019to 9 Jul 2020
- 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
- Intubation and mechanical ventilation since 24 hours
- Failure to a first ventilator liberating trial
- nasogastric feeding tube in place
- readiness criteria to undertake a ventilator liberating trial (Boles et al. ERJ 2007)
- patient written consent or next of kin written consent in case of physical inability of the patient to sign the consent form
- french social Health Service registration
Who cannot join
- pregnancy
- protective administrative control
- patient's refusal
- contra indications to the insertion of esophageal and gastric balloons
- allergy to topical anesthetic
- impossible weaning (full dependance to mechanical ventilation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diaphragmatic Function in Mechanically Ventilated Patients With Transient Shear Wave Elastography
Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient unloading. Evaluating diaphragm function is therefore crucial to optimally tailor the ventilator assistance. Measurement of transdiaphragmatic pressure (Pdi) is the reference method to assess diaphragm function but it invasiveness hinders the generalization of its use. Previous studies have reported that ultrasound can quantify diaphragm thickening and that diaphragm thickening fraction (TFdi) is a good marker of diaphragm function. Since diaphragm becomes stiffer when it contracts, the investigators aim at exploring whether the measurement of diaphragm stiffness by transient shear wave elastography would improve the evaluation of diaphragm function with ultrasound.
Therefore, the objectives of the study are to evaluate the performance of transient shear wave elastography applied to the diaphragm to estimate Pdi in mechanically ventilated patients as compared to TFdi and to correlate the changes in elastography derived indices, in TFdi and in Pdi into different ventilatory conditions and during a spontaneous breathing trial. Pdi will be obtained using catheters positioned in patients' stomachs and esophagus and diaphragm stiffness will be assessed by measuring the shear modulus of the diaphragm with a dedicated ultrasound machine (Aixplorer, Ultrasonic). TFdi will be also measured as previously reported. Pdi, TFdi and shear modulus will be measured at the end of each four following 10 minutes-conditions: 1) baseline with initial ventilator settings (set by the physician in charge of patient); 2) 25%-increase in pressure support and initial PEEP; 3) 25%-decrease in pressure support and initial PEEP and 4) initial level of pressure support and ZEEP. Finally, the same measurements will be done at the beginning of a 30 minutes spontaneous breathing trial.
Read the detailed description
Objective :
The main objective is to correlate ultrasound indices (thickness, thickening, rigidity) to the measurement of transdiaphragmatic pressure in the evaluation of the diaphragmatic function of patients under mechanical ventilation.
Secondary objectives are: 1. Correlate thickening of the diaphragm with Pdi, 2. Correlate diaphragmatic thickening with diaphragmatic stiffness 3. Describe these correlations under different levels of pressure ventilatory support, 4. Describe the evolution of diaphragmatic stiffness, thickening and Pdi pressure during a ventilator liberating trial.
The primary endpoint is the measurement of Pdi. The secondary endpoints are the diaphragm thickening fraction and diaphragm stiffness.
Methods :
The Pdi will be obtained by measuring the esophageal and gastric pressures through nasogastric tube equipped with balloons. The position of each of the balloons will be checked by displaying the esophageal and gastric pressure lines. The intragastric position will be confirmed by mild abdominal compression. The oesophageal position is based on visualization of cardiac artifacts on the pressure pattern and signal deflations related to inspiratory movements. The signals of the esophageal and gastric pressures will be displayed continuously and their resultant - transdiapragmatic pressure - will be automatically calculated in real time by the software. It will also record pressure in the airways at the endotracheal tube.
Patients will be placed in half-sitting position to allow better recognition of the diaphragm. Using the ultrasound system Aixplorer® (Aix en Provence, France V9), equipped with a high resolution probe (6 MHz). The probe will be positioned at the intercostal space above the tenth rib on the right axillary line and directed perpendicular to the diaphragm (apposition zone). The measurements will be performed "offline" and the calculation of the thickening fraction will be performed in blind clinical conditions.
The diaphragmatic elastography will be determined using the same ultrasound system (Aixplorer®, Aix en Provence, France V9, provided with a high resolution probe (SL10-2, central frequency, 6 MHz)). The anatomical approach is the same as the intercostal approach described previously. After finding the diaphragm in B mode, a transition to SWE (elastography) mode will be performed. Three successive measurements will be made on the same region of interest, the average of the three measurements will be retained. The variation of the shear modulus during the inspiratory time will also be calculated post hoc. As for standard ultrasound, records analysis will be performed in blind conditions.
Pdi, ultrasound derived indices and shear wave modulus will be measured under several conditions.
- At baseline: initial ventilator settings set by the physician in charge of patient
- 25%-increase in pressure support and initial PEEP during 10 minutes
- 25%-decrease in pressure support and initial PEEP during 10 minutes
- initial level of pressure support without PEEP (PEEP = 0) during 10 minutes
- Measurement of the maximal inspiratory pressure during an inspiratory occlusion maneuver lasting 20 seconds.
- A 30 minutes Ventilator liberating trial without PEEP nor Pressure Support (CPAP=0)
- Conditions
- Ventilator Weaning, Intensive Care Unit
- Being tested
- Shear Wave Elastography
- Keywords
- Shear wave elastography, Ultrasonography, Transdiaphragmatic pressure, Diaphragmatic function, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave ElastographyDevice
Ultrasound technology to assess tissue stiffness
| Study group | Role | What they receive |
|---|---|---|
| Ventilator liberating trial | Experimental | The diaphragmatic function of patients undergoing a ventilator liberating trial will be determined with transient shear wave elastography. Receives: Device: Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transdiaphragmatic pressure
Reference method to assess diaphragm function computed as the difference between esophageal pressure and gastric pressure
Measured: Through patient participation, an average of 1 day
Secondary outcomes (3)
Change in diaphragm thickness and thickening as expressed by the thickening fraction (ratio of the difference between inspiratory and expiratory thickness over expiratory thickness).
Using the ultrasound system Aixplorer® (Aix en Provence, France V9), equipped with a high resolution probe (6 MHz), anatomical structures will be identify using B-mode. A switch to TM-mode will allow us to measure the thickening fraction. A second switch to shear wave elastography allows to identify an elastography map of the diaphragm and calculate an average of the shear wave modulus.
Measured: Through patient participation, an average of 1 day
Change in diaphragm stiffness
Using the ultrasound system Aixplorer® (Aix en Provence, France V9), equipped with a high resolution probe (6 MHz), anatomical structures will be identify using B-mode. A switch to TM-mode will allow us to measure the thickening fraction. A second switch to shear wave elastography allows to identify an elastography map of the diaphragm and calculate an average of the shear wave modulus.
Measured: Through patient participation, an average of 1 day
Success or failure at the spontaneous breathing trial
Presence of clinical intolerance criteria according to Boles et al. ERJ 20107
Measured: Through patient participation, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start14 Feb 2019
- Primary completion15 Feb 2019
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin DRES, MD, PhD, Principal investigator, Assistance Publique Hoptiaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832231
- Sponsor's protocol ID
- APHP180264
- Other IDs
- 2018-A02311-54
- Acronym
- Elasto-ICU
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fosse Q, Poulard T, Nierat MC, Virolle S, Morawiec E, Hogrel JY, Similowski T, Demoule A, Gennisson JL, Bachasson D, Dres M. Ultrasound shear wave elastography for assessing diaphragm function in mechanically ventilated patients: a breath-by-breath analysis. Crit Care. 2020 Nov 27;24(1):669. doi: 10.1186/s13054-020-03338-y.
PubMed 33246478
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragmatic Function in Mechanically Ventilated Patients With Transient Shear Wave Elastography
- ClinicalTrials.gov ID
- NCT03832231
- Acronym / sponsor ID
- Elasto-ICU / APHP180264
- Conditions
- Ventilator Weaning, Intensive Care Unit
- Keywords
- Shear wave elastography, Ultrasonography, Transdiaphragmatic pressure, Diaphragmatic function, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 6 Feb 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.
Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient unloading. Evaluating diaphragm function is therefore crucial to optimally tailor the ventilator assistance. Measurement of transdiaphragmatic pressure (Pdi) is the reference method to assess diaphragm function but it invasiveness hinders the generalization of its use. Previous studies have reported that ultrasound can quantify diaphragm thickening and that diaphragm thickening fraction (TFdi) is a good marker of diaphragm function. Since diaphragm becomes stiffer when it contracts, the investigators aim at exploring whether the measurement of diaphragm stiffness by transient shear wave elastography would improve the evaluation of diaphragm function with ultrasound.
Therefore, the objectives of the study are to evaluate the performance of transient shear wave elastography applied to the diaphragm to estimate Pdi in mechanically ventilated patients as compared to TFdi and to correlate the changes in elastography derived indices, in TFdi and in Pdi into different ventilatory conditions and during a spontaneous breathing trial. Pdi will be obtained using catheters positioned in patients' stomachs and esophagus and diaphragm stiffness will be assessed by measuring the shear modulus of the diaphragm with a dedicated ultrasound machine (Aixplorer, Ultrasonic). TFdi will be also measured as previously reported. Pdi, TFdi and shear modulus will be measured at the end of each four following 10 minutes-conditions: 1) baseline with initial ventilator settings (set by the physician in charge of patient); 2) 25%-increase in pressure support and initial PEEP; 3) 25%-decrease in pressure support and initial PEEP and 4) initial level of pressure support and ZEEP. Finally, the same measurements will be done at the beginning of a 30 minutes spontaneous breathing trial.
Detailed description
Objective :
The main objective is to correlate ultrasound indices (thickness, thickening, rigidity) to the measurement of transdiaphragmatic pressure in the evaluation of the diaphragmatic function of patients under mechanical ventilation.
Secondary objectives are: 1. Correlate thickening of the diaphragm with Pdi, 2. Correlate diaphragmatic thickening with diaphragmatic stiffness 3. Describe these correlations under different levels of pressure ventilatory support, 4. Describe the evolution of diaphragmatic stiffness, thickening and Pdi pressure during a ventilator liberating trial.
The primary endpoint is the measurement of Pdi. The secondary endpoints are the diaphragm thickening fraction and diaphragm stiffness.
Methods :
The Pdi will be obtained by measuring the esophageal and gastric pressures through nasogastric tube equipped with balloons. The position of each of the balloons will be checked by displaying the esophageal and gastric pressure lines. The intragastric position will be confirmed by mild abdominal compression. The oesophageal position is based on visualization of cardiac artifacts on the pressure pattern and signal deflations related to inspiratory movements. The signals of the esophageal and gastric pressures will be displayed continuously and their resultant - transdiapragmatic pressure - will be automatically calculated in real time by the software. It will also record pressure in the airways at the endotracheal tube.
Patients will be placed in half-sitting position to allow better recognition of the diaphragm. Using the ultrasound system Aixplorer® (Aix en Provence, France V9), equipped with a high resolution probe (6 MHz). The probe will be positioned at the intercostal space above the tenth rib on the right axillary line and directed perpendicular to the diaphragm (apposition zone). The measurements will be performed "offline" and the calculation of the thickening fraction will be performed in blind clinical conditions.
The diaphragmatic elastography will be determined using the same ultrasound system (Aixplorer®, Aix en Provence, France V9, provided with a high resolution probe (SL10-2, central frequency, 6 MHz)). The anatomical approach is the same as the intercostal approach described previously. After finding the diaphragm in B mode, a transition to SWE (elastography) mode will be performed. Three successive measurements will be made on the same region of interest, the average of the three measurements will be retained. The variation of the shear modulus during the inspiratory time will also be calculated post hoc. As for standard ultrasound, records analysis will be performed in blind conditions.
Pdi, ultrasound derived indices and shear wave modulus will be measured under several conditions.
- At baseline: initial ventilator settings set by the physician in charge of patient
- 25%-increase in pressure support and initial PEEP during 10 minutes
- 25%-decrease in pressure support and initial PEEP during 10 minutes
- initial level of pressure support without PEEP (PEEP = 0) during 10 minutes
- Measurement of the maximal inspiratory pressure during an inspiratory occlusion maneuver lasting 20 seconds.
- A 30 minutes Ventilator liberating trial without PEEP nor Pressure Support (CPAP=0)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilator liberating trial | Experimental | Device: Shear Wave ElastographyThe diaphragmatic function of patients undergoing a ventilator liberating trial will be determined with transient shear wave elastography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Intubation and mechanical ventilation since 24 hours
- Failure to a first ventilator liberating trial
- nasogastric feeding tube in place
- readiness criteria to undertake a ventilator liberating trial (Boles et al. ERJ 2007)
Key exclusion criteria (6 listed)
- pregnancy
- protective administrative control
- patient's refusal
- contra indications to the insertion of esophageal and gastric balloons
- allergy to topical anesthetic
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 |
|---|---|---|
| Shear Wave ElastographyUltrasound technology to assess tissue stiffness | Device | Ventilator liberating trial |
Primary outcome
Change in transdiaphragmatic pressure
Time frame: Through patient participation, an average of 1 day
Reference method to assess diaphragm function computed as the difference between esophageal pressure and gastric pressure
3 secondary outcomes
Change in diaphragm thickness and thickening as expressed by the thickening fraction (ratio of the difference between inspiratory and expiratory thickness over expiratory thickness).
Time frame: Through patient participation, an average of 1 day
Change in diaphragm stiffness
Time frame: Through patient participation, an average of 1 day
Success or failure at the spontaneous breathing trial
Time frame: Through patient participation, an average of 1 day
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 1 Mar 2021.
- Derived from this study: PubMed 33246478Fosse Q, Poulard T, Nierat MC, Virolle S, Morawiec E, Hogrel JY, Similowski T, Demoule A, Gennisson JL, Bachasson D, Dres M. Ultrasound shear wave elastography for assessing diaphragm function in mechanically ventilated patients: a breath-by-breath analysis. Crit Care. 2020 Nov 27;24(1):669. doi: 10.1186/s13054-020-03338-y.
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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.
Martin DRES, MD, PhD principal investigator
Assistance Publique Hoptiaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Elastography in people with Ventilator Weaning and Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 6 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 1 Mar 2021. 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?
Change in transdiaphragmatic pressure (time frame: Through patient participation, an average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832231, which also lists 1 linked publication.
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 1 Mar 2021.