ARDSNCT01289600
Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
A study testing Mechanical ventilation in people with ARDS, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Mar 2013
- 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
- intubated, mechanically ventilated patients
- meeting criteria for ARDS
- mean arterial blood pressure > 65 mmHg (with or w/o vasopressors)
Who cannot join
- pregnancy
- increased intracranial pressure
- contra-indication naso-gastric tube
- diagnosed neuro-muscular disorder
- recent (<12 hours) use of muscle relaxants
- exclusion from sedation interruption protocol as used in our institution
Show all 9Show fewer
- open chest or- abdomen
- very high inspiratory flow rate during supported ventilation
- inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Nijmegen
Nijmegen, Gelderland, 6525 GA
About this study
Official title: The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)
The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation.
- Conditions
- ARDS
- Being tested
- Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Also called Maquet Servo-i
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
| Study group | Role | What they receive |
|---|---|---|
| Pressure support ventilation, ARDSnet | Active comparator | Mechanical ventilator is set to pressure support ventilation (6 ml/kg) for 30 min with positive end expiratory pressure (PEEP) set according to the "higher arm" of the ARDS network consensus. Receives: Device: Mechanical ventilation |
| Pressure control ventilation, ARDSnet | Active comparator | Mechanical ventilator is set to pressure control ventilation (6 ml/kg) for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus. Receives: Device: Mechanical ventilation |
| Neurally adjusted ventilatory assist, ARDSnet | Active comparator | Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus. Receives: Device: Mechanical ventilation |
| Neurally adjusted ventilatory assist, titrated | Active comparator | Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal. Receives: Device: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure-time product of the diaphragm
The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Measured: average of last 15 minutes of each study arm
Patient - ventilator asynchrony index
Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Measured: average of last 15 minutes of each study arm
Secondary outcomes (4)
Transpulmonary pressure
Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Measured: average of last 15 minutes of each study arm
Transdiaphragmatic pressure
Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Measured: average of last 15 minutes of each study arm
Oxygenation index
Oxygenation index is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen. Arterial oxygen tension is obtained at the end of each study arm.
Measured: at the end of each study arm
Dead space ventilation
Dead space ventilation is determined each breath using the Bohr equation: (PaCO2-PeCO2/PaCO2)*Vt. Here Vt is tidal volume, PaCO2 is the partial pressure of carbon dioxide in the arterial blood, and PeCO2 is the end-tidal carbon dioxide tension in the expired air. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Measured: average of last 15 minutes of each study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Heunks, University Medical Center Nijmegen
- Investigators
- Leo Heunks, MD, PhD, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289600
- Sponsor's protocol ID
- ARDS1
- Status last verified
- Jun 2015
- First submitted
- 27 Jan 2011
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT01289600
- Acronym / sponsor ID
- ARDS1
- Conditions
- ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Feb 2011 (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.
The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pressure support ventilation, ARDSnet | Active comparator | Device: Mechanical ventilationMechanical ventilator is set to pressure support ventilation (6 ml/kg) for 30 min with positive end expiratory pressure (PEEP) set according to the "higher arm" of the ARDS network consensus. |
| Pressure control ventilation, ARDSnet | Active comparator | Device: Mechanical ventilationMechanical ventilator is set to pressure control ventilation (6 ml/kg) for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus. |
| Neurally adjusted ventilatory assist, ARDSnet | Active comparator | Device: Mechanical ventilationMechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus. |
| Neurally adjusted ventilatory assist, titrated | Active comparator | Device: Mechanical ventilationMechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- intubated, mechanically ventilated patients
- meeting criteria for ARDS
- mean arterial blood pressure > 65 mmHg (with or w/o vasopressors)
Key exclusion criteria (9 listed)
- pregnancy
- increased intracranial pressure
- contra-indication naso-gastric tube
- diagnosed neuro-muscular disorder
- recent (<12 hours) use of muscle relaxants
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 |
|---|---|---|
| Mechanical ventilationAlso: Maquet Servo-iThe mechanical ventilator is set to different ventilation modes as described in the individual arms. | Device | Neurally adjusted ventilatory assist, ARDSnet, Neurally adjusted ventilatory assist, titrated, Pressure control ventilation, ARDSnet, Pressure support ventilation, ARDSnet |
Primary outcome
Pressure-time product of the diaphragm
Time frame: average of last 15 minutes of each study arm
The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Patient - ventilator asynchrony index
Time frame: average of last 15 minutes of each study arm
Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
4 secondary outcomes
Transpulmonary pressure
Time frame: average of last 15 minutes of each study arm
Transdiaphragmatic pressure
Time frame: average of last 15 minutes of each study arm
Oxygenation index
Time frame: at the end of each study arm
Dead space ventilation
Time frame: average of last 15 minutes of each study arm
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 10 Jun 2015.
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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 Heunks, MD, PhD principal investigator
Radboud University Nijmegen Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation in people with ARDS, run by University Medical Center Nijmegen 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 9 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 10 Jun 2015. 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?
Pressure-time product of the diaphragm (time frame: average of last 15 minutes of each study arm). 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?
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 10 Jun 2015.