Diaphragm InjuryEdi2PdiNCT03580720
Electromyography for Diaphragm Effort
A study testing Inspiratory threshold loading protocol in people with Diaphragm Injury and Muscle Weakness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Mechanical ventilation may be necessary to save the life of a patient due to an accident, pneumonia or surgery. The ventilator then temporarily takes over the function of the respiratory muscles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Injury, Muscle Weakness, Weaning Failure
- What is being tested?
- Inspiratory threshold loading protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 May 2018to 30 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent
- Age >18 years
Who cannot join
- History of cardiac and/or pulmonary disease or current medication use
- History of pneumothorax
- Contra-indications for nasogastric tube placement (recent epistaxis, severe coagulopathy, current upper airway pathology)
- Contra-indication for magnetic stimulation (cardiac pacemakers or metal in cervical area)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081HV
About this study
Official title: Diaphragm Electromyography to Estimate Breathing Effort: a Physiological Study
Mechanical ventilation may be necessary to save the life of a patient due to an accident, pneumonia or surgery. The ventilator then temporarily takes over the function of the respiratory muscles. During treatment in the Intensive Care, the amount of support provided by the ventilator is usually lowered gradually, until the point that the patient can breathe unassisted once again. However, in a large fraction of patients (up to 40%) it takes days to weeks before the patient is able to breathe unassisted, even after the initial disease has been treated. This is called prolonged weaning.
A possible cause of prolonged weaning is weakness of the respiratory muscles. The diaphragm, the largest respiratory muscle, can become weakened if it is used too little, much like all other muscles in the body. Additionally, damage and weakness of the diaphragm can occur when the diaphragm has to work excessively. Therefore, it is important that the diaphragm works enough; not so little that it becomes weakened, but not too much either.
Read more
Measurements of pressure generated by the diaphragm are needed to determine the current level of diaphragm activity in a patient on mechanical ventilation. However, these measurements are rarely performed, because they are time-consuming and require placement of two additional nasogastric catheters. This is a shame, as adequate loading of the diaphragm might prevent development of weakness, leading to shorter duration of mechanical ventilation. Finding alternative measurements of diaphragm effort might be a solution to this problem.
It has been hypothesized that the electrical activity of the diaphragm provides a reliable indication of diaphragm effort. This study aims to determine whether there is a correlation between pressure generation by the diaphragm and electrical activity of the diaphragm over a wide range of respiratory activity, from low effort to extreme effort, in healthy volunteers.
- Being tested
- Inspiratory threshold loading protocol
- Keywords
- Monitoring, Breathing effort, Intensive Care, Diaphragm weakness
- Medical subject headings
- Muscle Weakness, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory threshold loading protocolOther
Subjects will be instrumented with catheters that measure electrical activity of the diaphragm and transdiaphragmatic pressure. Subjects will perform a stepwise inspiratory threshold loading protocol to induce a wide range of diaphragm activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group, receiving Inspiratory threshold loading protocol. Receives: Other: Inspiratory threshold loading protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical activity of the diaphragm
Diaphragm electromyography will be obtained with multiple electrode pairs situated on specialized esophageal catheters. The raw diaphragm electromyography will be filtered and integrated to obtain the compound mean action potential reported in microvolts (μV) as described in ref 1 (Sinderby et al.).
Measured: Electrical activity of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
Transdiaphragmatic pressure
The pressure gradient over the diaphragm will be obtained by subtracting the esophageal pressure from the pressure in the stomach, measured with specialized catheters, and will be reported in centimeters of water (cmH2O) as described in ref 3, American Thoracic Society (ATS) statement on respiratory muscle testing.
Measured: Transdiaphragmatic pressure will be assessed at multiple levels of breathing effort in each subject for two hours.
Secondary outcomes (4)
Work of breathing
Work of breathing will be obtained by integrating the pressure-volume loops of esophageal pressure and tidal volume, and will be reported in Joule per minute as described in ref 3, ATS statement on respiratory muscle testing..
Measured: Work of breathing will be assessed at multiple levels of breathing effort in each subject for two hours.
Pressure-time product of the diaphragm
Pressure-time product of the diaphragm will be obtained by dividing the time-integral of transdiaphragmatic pressure (described above) over time, and will be reported as cmH20*s per minute as described in ref 3, ATS statement on respiratory muscle testing..
Measured: Pressure-time product of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
Pressure-time product of the respiratory muscles
Pressure-time product of the respiratory muscles will be obtained by dividing the time-integral of esophageal pressure over time, and will be reported as cmH20*s per minute as described in ref 3, ATS statement on respiratory muscle testing..
Measured: Pressure-time product of the respiratory muscles will be assessed at multiple levels of breathing effort in each subject for two hours.
Mechanical power
Mechanical power will be obtained by multiplying the work of breathing (described above) by the number of breaths per minute, and will be reported in Watt (joule/minute) as described in ref 3, ATS statement on respiratory muscle testing..
Measured: Mechanical power will be assessed at multiple levels of breathing effort in each subject for two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start16 May 2018
- Primary completion15 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diaphragm InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. L.M.A. Heunks, Amsterdam UMC, location VUmc
- Investigators
- Angelique Spoelstra - de Man, MD, PhD, Study chair, Amsterdam UMC, location VUmcLeo Heunks, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580720
- Sponsor's protocol ID
- NL64648.029.18
- Acronym
- Edi2Pdi
- Status last verified
- May 2020
- First submitted
- 8 Jun 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sinderby CA, Beck JC, Lindstrom LH, Grassino AE. Enhancement of signal quality in esophageal recordings of diaphragm EMG. J Appl Physiol (1985). 1997 Apr;82(4):1370-7. doi: 10.1152/jappl.1997.82.4.1370.
PubMed 9104877Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
PubMed 22476448American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Electromyography to Estimate Breathing Effort: a Physiological Study
- ClinicalTrials.gov ID
- NCT03580720
- Acronym / sponsor ID
- Edi2Pdi / NL64648.029.18
- Keywords
- Monitoring, Breathing effort, Intensive Care, Diaphragm weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 9 Jul 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.
Mechanical ventilation may be necessary to save the life of a patient due to an accident, pneumonia or surgery. The ventilator then temporarily takes over the function of the respiratory muscles. During treatment in the Intensive Care, the amount of support provided by the ventilator is usually lowered gradually, until the point that the patient can breathe unassisted once again. However, in a large fraction of patients (up to 40%) it takes days to weeks before the patient is able to breathe unassisted, even after the initial disease has been treated. This is called prolonged weaning.
A possible cause of prolonged weaning is weakness of the respiratory muscles. The diaphragm, the largest respiratory muscle, can become weakened if it is used too little, much like all other muscles in the body. Additionally, damage and weakness of the diaphragm can occur when the diaphragm has to work excessively. Therefore, it is important that the diaphragm works enough; not so little that it becomes weakened, but not too much either.
Measurements of pressure generated by the diaphragm are needed to determine the current level of diaphragm activity in a patient on mechanical ventilation. However, these measurements are rarely performed, because they are time-consuming and require placement of two additional nasogastric catheters. This is a shame, as adequate loading of the diaphragm might prevent development of weakness, leading to shorter duration of mechanical ventilation. Finding alternative measurements of diaphragm effort might be a solution to this problem.
It has been hypothesized that the electrical activity of the diaphragm provides a reliable indication of diaphragm effort. This study aims to determine whether there is a correlation between pressure generation by the diaphragm and electrical activity of the diaphragm over a wide range of respiratory activity, from low effort to extreme effort, in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Inspiratory threshold loading protocolIntervention group, receiving Inspiratory threshold loading protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent
- Age >18 years
Key exclusion criteria (4 listed)
- History of cardiac and/or pulmonary disease or current medication use
- History of pneumothorax
- Contra-indications for nasogastric tube placement (recent epistaxis, severe coagulopathy, current upper airway pathology)
- Contra-indication for magnetic stimulation (cardiac pacemakers or metal in cervical area)
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 |
|---|---|---|
| Inspiratory threshold loading protocolSubjects will be instrumented with catheters that measure electrical activity of the diaphragm and transdiaphragmatic pressure. Subjects will perform a stepwise inspiratory threshold loading protocol to induce a wide range of diaphragm activity. | Other | Intervention |
Primary outcome
Electrical activity of the diaphragm
Time frame: Electrical activity of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
Diaphragm electromyography will be obtained with multiple electrode pairs situated on specialized esophageal catheters. The raw diaphragm electromyography will be filtered and integrated to obtain the compound mean action potential reported in microvolts (μV) as described in ref 1 (Sinderby et al.).
Transdiaphragmatic pressure
Time frame: Transdiaphragmatic pressure will be assessed at multiple levels of breathing effort in each subject for two hours.
The pressure gradient over the diaphragm will be obtained by subtracting the esophageal pressure from the pressure in the stomach, measured with specialized catheters, and will be reported in centimeters of water (cmH2O) as described in ref 3, American Thoracic Society (ATS) statement on respiratory muscle testing.
4 secondary outcomes
Work of breathing
Time frame: Work of breathing will be assessed at multiple levels of breathing effort in each subject for two hours.
Pressure-time product of the diaphragm
Time frame: Pressure-time product of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.
Pressure-time product of the respiratory muscles
Time frame: Pressure-time product of the respiratory muscles will be assessed at multiple levels of breathing effort in each subject for two hours.
Mechanical power
Time frame: Mechanical power will be assessed at multiple levels of breathing effort in each subject for two hours.
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 20 May 2020.
- Background: PubMed 9104877Sinderby CA, Beck JC, Lindstrom LH, Grassino AE. Enhancement of signal quality in esophageal recordings of diaphragm EMG. J Appl Physiol (1985). 1997 Apr;82(4):1370-7. doi: 10.1152/jappl.1997.82.4.1370.
- Background: PubMed 22476448Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Angelique Spoelstra - de Man, MD, PhD study chair
Amsterdam UMC, location VUmc
Leo Heunks, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory threshold loading protocol in people with Diaphragm Injury and Muscle Weakness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 2 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 20 May 2020. 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 Netherlands. 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?
Electrical activity of the diaphragm (time frame: Electrical activity of the diaphragm will be assessed at multiple levels of breathing effort in each subject for two hours.). The study lists 2 primary outcomes in all. 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 NCT03580720, which also lists 3 linked publications.
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 20 May 2020.