Critical IllnessDiaProNCT03527797
Diaphragm Protective Ventilation in the Intensive Care Unit
A study testing Titration of support level in people with Critical Illness and Muscle Weakness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Due to an accident, pneumonia or surgery, patients can have severe shortness of breath or lung damage to such an extent that it compromises vital functions. At such times, mechanical ventilation can be lifesaving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Muscle Weakness, Muscle Damage
- What is being tested?
- Titration of support level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 May 2018to 18 Oct 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
- Informed consent
- Receives partially supported mechanical ventilation
- Estimated duration of mechanical ventilation after inclusion of at least 24 hours, as estimated by the attending physician
Who cannot join
- Known neuromuscular disease
- Contra-indications for nasogastric intubation (upper airway surgery, bleeding disorders)
- Expected difficulties in obtaining reliable pressure measurements, such as known airleak into pleural space or diaphragmatic herniation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University medical center
Amsterdam, North Holland, 1081HV
About this study
Official title: Diaphragm-protective Mechanical Ventilation in Critically Ill Patients: A Randomized Controlled Pilot Study
Due to an accident, pneumonia or surgery, patients can have severe shortness of breath or lung damage to such an extent that it compromises vital functions. At such times, mechanical ventilation can be lifesaving. The ventilator temporarily takes over the function of the respiratory muscles to ensure adequate uptake of oxygen and removal of carbon dioxide. Mechanical ventilation can usually be stopped quickly after the initial disease has been treated. Unfortunately, in up to 25-40% of ventilated patients it takes several days to weeks before mechanical ventilation can be discontinued, even after treatment of the initial disease. This phenomenon is termed weaning failure. Weakness of the respiratory muscles, such as the diaphragm, is one of the leading causes of weaning failure.
Like other skeletal muscles, the diaphragm can become weakened if it is used too little. This happens often during mechanical ventilation because of excessive assistance provided by the ventilator or use of sedative medication. Excessive activity of the diaphragm can also lead to damage and weakness, just like in other muscles that have to perform excessive amounts for a prolonged period of time. Additionally, excessive work by the diaphragm might have a direct damaging effect on the lungs, which leads to a vicious cycle. As such, it is very important to find a balance between resting the diaphragm (which may lead to weakness) and placing excessive work on the diaphragm (which can damage the diaphragm and possibly the lungs).
In this study, the investigators want to test whether insufficient activity and excessive activity of the diaphragm during mechanical ventilation can be prevented or reduced. The investigators plan to measure the diaphragm activity in 40 participants on mechanical ventilation. Participants will be randomly assigned to the intervention group or the control group. In the intervention group, ventilator support levels will be adjusted according to the observed diaphragm activity, in an attempt to ensure adequate diaphragm activity. The control group receives usual care. The hypothesis is that adjusting the level of support provided by the ventilator is a feasible method to improve the time that the diaphragm operates within acceptable levels of activity over a 24 hour period.
- Conditions
- Critical Illness, Muscle Weakness, Muscle Damage, Respiration, Artificial, Respiratory, Diaphragm
- Being tested
- Titration of support level
- Keywords
- Critical illness associated diaphragm weakness, Mechanical ventilation, Critical illness, Respiratory muscle dysfunction
- Medical subject headings
- Critical Illness, Muscle Weakness, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of support levelOther
Increasing support in case diaphragm activity is too high. Decreasing support in case diaphragm activity is too low.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Intervention | Experimental | Titration of support level Receives: Other: Titration of support level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate diaphragm loading
Percentage of time that the diaphragm operates within physiological levels of activity (Transdiaphragmatic pressure per breath between 3-12 cmH2O).
Measured: 24 hours
Secondary outcomes (4)
Pressure-time product of diaphragm activity
Average pressure-time product of the diaphragm calculated as the time-integral of transdiaphragmatic pressure, reported and compared between intervention and control
Measured: 24 hours
Work of breathing
Average work per breath and work per minute, calculated as the volume-pressure integral of esophageal pressure, reported and compared between intervention and control
Measured: 24 hours
Markers for lung-protective ventilation
Average transpulmonary pressure, tidal volumes, plateau airway pressures, markers for systemic inflammation and mechanical power reported and compared between intervention and control
Measured: 24 hours
Patient ventilator interaction
Average percentage of asynchrony events, calculated as number of asynchronies / total breathing cycles * 100%, reported and compared between intervention and control
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start16 May 2018
- Primary completion16 Jul 2020
- Study completion18 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 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
- Leo M Heunks, MD, PhD, Principal investigator, Professor of Experimental Intensive CareAngélique Spoelstra - de Man, MD, PhD, Study chair, Intensivist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527797
- Sponsor's protocol ID
- NL62486.029.17
- Acronym
- DiaPro
- Status last verified
- Mar 2021
- First submitted
- 24 Apr 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm-protective Mechanical Ventilation in Critically Ill Patients: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03527797
- Acronym / sponsor ID
- DiaPro / NL62486.029.17
- Conditions
- Critical Illness, Muscle Weakness, Muscle Damage, Respiration, Artificial, Respiratory, Diaphragm
- Keywords
- Critical illness associated diaphragm weakness, Mechanical ventilation, Critical illness, Respiratory muscle dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 18 Oct 2020 (actual)
- First posted
- 17 May 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.
Due to an accident, pneumonia or surgery, patients can have severe shortness of breath or lung damage to such an extent that it compromises vital functions. At such times, mechanical ventilation can be lifesaving. The ventilator temporarily takes over the function of the respiratory muscles to ensure adequate uptake of oxygen and removal of carbon dioxide. Mechanical ventilation can usually be stopped quickly after the initial disease has been treated. Unfortunately, in up to 25-40% of ventilated patients it takes several days to weeks before mechanical ventilation can be discontinued, even after treatment of the initial disease. This phenomenon is termed weaning failure. Weakness of the respiratory muscles, such as the diaphragm, is one of the leading causes of weaning failure.
Like other skeletal muscles, the diaphragm can become weakened if it is used too little. This happens often during mechanical ventilation because of excessive assistance provided by the ventilator or use of sedative medication. Excessive activity of the diaphragm can also lead to damage and weakness, just like in other muscles that have to perform excessive amounts for a prolonged period of time. Additionally, excessive work by the diaphragm might have a direct damaging effect on the lungs, which leads to a vicious cycle. As such, it is very important to find a balance between resting the diaphragm (which may lead to weakness) and placing excessive work on the diaphragm (which can damage the diaphragm and possibly the lungs).
In this study, the investigators want to test whether insufficient activity and excessive activity of the diaphragm during mechanical ventilation can be prevented or reduced. The investigators plan to measure the diaphragm activity in 40 participants on mechanical ventilation. Participants will be randomly assigned to the intervention group or the control group. In the intervention group, ventilator support levels will be adjusted according to the observed diaphragm activity, in an attempt to ensure adequate diaphragm activity. The control group receives usual care. The hypothesis is that adjusting the level of support provided by the ventilator is a feasible method to improve the time that the diaphragm operates within acceptable levels of activity over a 24 hour period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Intervention | Experimental | Other: Titration of support levelTitration of support level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Receives partially supported mechanical ventilation
- Estimated duration of mechanical ventilation after inclusion of at least 24 hours, as estimated by the attending physician
Key exclusion criteria (3 listed)
- Known neuromuscular disease
- Contra-indications for nasogastric intubation (upper airway surgery, bleeding disorders)
- Expected difficulties in obtaining reliable pressure measurements, such as known airleak into pleural space or diaphragmatic herniation
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 |
|---|---|---|
| Titration of support levelIncreasing support in case diaphragm activity is too high. Decreasing support in case diaphragm activity is too low. | Other | Intervention |
Primary outcome
Adequate diaphragm loading
Time frame: 24 hours
Percentage of time that the diaphragm operates within physiological levels of activity (Transdiaphragmatic pressure per breath between 3-12 cmH2O).
4 secondary outcomes
Pressure-time product of diaphragm activity
Time frame: 24 hours
Work of breathing
Time frame: 24 hours
Markers for lung-protective ventilation
Time frame: 24 hours
Patient ventilator interaction
Time frame: 24 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 18 Mar 2021.
- 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.
Leo M Heunks, MD, PhD principal investigator
Professor of Experimental Intensive Care
Angélique Spoelstra - de Man, MD, PhD study chair
Intensivist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of support level in people with Critical Illness 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 3 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 18 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 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?
Adequate diaphragm loading (time frame: 24 hours). 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 18 Mar 2021.