Diaphragm DiseaseNCT03539640
Effect PEEP on Diaphragm
A study testing PEEP: 5 cmH2O, PEEP: 10 cmH2O and PEEP: 15 cmH2O in people with Diaphragm Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This study evaluates the effect of positive end-expiratory pressure on the position, length and function of the diaphragm. During the first part of the study, physiological measurements of the diaphragm will be performed while participants receive non-invasive ventilation at different PEEP levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Disease
- What is being tested?
- PEEP: 5 cmH2O, PEEP: 10 cmH2O and PEEP: 15 cmH2O
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Apr 2018to 1 May 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
- Signed informed consent
- Age ≥ 18 years
Who cannot join
- Symptoms relating to respiratory or cardiovascular disease
- History of pneumothorax or family history of primary pneumothorax
- Obesity (defined as BMI > 30kg/m²)
- Known pregnancy
- Contraindications for the placement of a nasogastric tube (upper airway/esophageal/gastric/mouth or face pathology (e.g. recent surgery, esophageal varices, diaphragmatic hernia), nasal bleeding within the last 2 weeks or use of anticoagulants)
- Contraindications for MRI (electrical/metallic implants, claustrophobia or history in metalworking)
- Subjects who are employed at the department of intensive care adults, directly involved in the study and/or family from staff of the ICU.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Positive End-expiratory Pressure on the Position, Length and Contractibility of the Diaphragm.
This study evaluates the effect of positive end-expiratory pressure on the position, length and function of the diaphragm. During the first part of the study, physiological measurements of the diaphragm will be performed while participants receive non-invasive ventilation at different PEEP levels. During the second part of the study, MRI measurements of the diaphragm will be performed during a change in PEEP level.
Read the detailed description
In almost all mechanically ventilated patients, positive end-expiratory pressure (PEEP) is used. Its function is to prevent alveolar collapse and to maintain oxygenation. However, it has recently been found that PEEP may contribute to diaphragm weakness, which is an important problem in the intensive care unit (ICU). This study showed that mechanical ventilation with PEEP resulted in a caudal displacement of the diaphragm, since PEEP increases the end-expiratory volume. Furthermore, their study in rats showed that this displacement resulted in a reduced fiber length and sarcomere length on the short term.
After rats were ventilated with PEEP for 18 hours, it was found that adaptation of the diaphragm occurred; i.e. the number of sarcomeres were decreased. It is hypothesized that this adaptation may also occur in mechanically ventilated patients. This could lead to problems in weaning a patient off the ventilator, as PEEP is abruptly removed during a spontaneous breathing trial (SBT). This leads to a reduction in end-expiratory volume which would mean that the newly-adapted diaphragm fibers are being stretched. These stretched muscle fibers are not working at their optimal length of the force-length relation, thereby contributing to diaphragm weakness.
- Conditions
- Diaphragm Disease
- Being tested
- PEEP: 5 cmH2O, PEEP: 10 cmH2O, PEEP: 15 cmH2O
- Keywords
- PEEP, Diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP: 5 cmH2OOther
During second part of the study (MRI)
PEEP: 10 cmH2OOther
During second part of the study (MRI)
PEEP: 15 cmH2OOther
During second part of the study (MRI)
| Study group | Role | What they receive |
|---|---|---|
| PEEP level of 5 cmH2O | Active comparator | During second part of the study (MRI) Diaphragm position Receives: Other: PEEP: 5 cmH2O |
| PEEP level of 10 cmH2O | Active comparator | During second part of the study (MRI) Diaphragm position Receives: Other: PEEP: 10 cmH2O |
| PEEP level of 15 cmH2O | Active comparator | During second part of the study (MRI) Diaphragm position Receives: Other: PEEP: 15 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diaphragm's position
Changes in the position of the diaphragm during different PEEP levels, as measured with both ultrasound and MRI
Measured: 2 hours
Changes in diaphragm's shape and length
Changes of the diaphragm's shape and length during different PEEP levels, as measured with MRI
Measured: 2 hours
Changes in diaphragm's efficiency
Changes in the neuro-mechanical efficiency of the diaphragm (ratio between pressure and electrical muscle activity) during different PEEP levels, as measured with a nasogastric catheter
Measured: 2 hours
Change in twitch transdiaphragmatic pressures
Twitch transdiaphragmatic pressures during different PEEP levels, as measured with magnetic stimulation of the phrenic nerves.
Measured: 2 hours
Secondary outcomes (1)
Difference between MRI and ultrasound
The difference between diaphragm parameters obtained by ultrasound and parameters obtained by MRI
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start13 Apr 2018
- Primary completion12 Dec 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive the same protocol with different levels of PEEP ventilation during the first part of the study (physiological part), so the interventional study model for this part is single group. During the second part (MRI), participants are randomized for one of the three available PEEP levels (5, 10 or 15 cmH2O), so the study model for this part is parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 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 Heunks, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539640
- Sponsor's protocol ID
- NL63905.029.17
- Status last verified
- May 2020
- First submitted
- 17 Apr 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
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
- The Effects of Positive End-expiratory Pressure on the Position, Length and Contractibility of the Diaphragm.
- ClinicalTrials.gov ID
- NCT03539640
- Acronym / sponsor ID
- NL63905.029.17
- Conditions
- Diaphragm Disease
- Keywords
- PEEP, Diaphragm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 29 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.
This study evaluates the effect of positive end-expiratory pressure on the position, length and function of the diaphragm. During the first part of the study, physiological measurements of the diaphragm will be performed while participants receive non-invasive ventilation at different PEEP levels. During the second part of the study, MRI measurements of the diaphragm will be performed during a change in PEEP level.
Detailed description
In almost all mechanically ventilated patients, positive end-expiratory pressure (PEEP) is used. Its function is to prevent alveolar collapse and to maintain oxygenation. However, it has recently been found that PEEP may contribute to diaphragm weakness, which is an important problem in the intensive care unit (ICU). This study showed that mechanical ventilation with PEEP resulted in a caudal displacement of the diaphragm, since PEEP increases the end-expiratory volume. Furthermore, their study in rats showed that this displacement resulted in a reduced fiber length and sarcomere length on the short term.
After rats were ventilated with PEEP for 18 hours, it was found that adaptation of the diaphragm occurred; i.e. the number of sarcomeres were decreased. It is hypothesized that this adaptation may also occur in mechanically ventilated patients. This could lead to problems in weaning a patient off the ventilator, as PEEP is abruptly removed during a spontaneous breathing trial (SBT). This leads to a reduction in end-expiratory volume which would mean that the newly-adapted diaphragm fibers are being stretched. These stretched muscle fibers are not working at their optimal length of the force-length relation, thereby contributing to diaphragm weakness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will receive the same protocol with different levels of PEEP ventilation during the first part of the study (physiological part), so the interventional study model for this part is single group. During the second part (MRI), participants are randomized for one of the three available PEEP levels (5, 10 or 15 cmH2O), so the study model for this part is parallel.
| Arm | Type | Receives |
|---|---|---|
| PEEP level of 5 cmH2O | Active comparator | Other: PEEP: 5 cmH2ODuring second part of the study (MRI) Diaphragm position |
| PEEP level of 10 cmH2O | Active comparator | Other: PEEP: 10 cmH2ODuring second part of the study (MRI) Diaphragm position |
| PEEP level of 15 cmH2O | Active comparator | Other: PEEP: 15 cmH2ODuring second part of the study (MRI) Diaphragm position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Symptoms relating to respiratory or cardiovascular disease
- History of pneumothorax or family history of primary pneumothorax
- Obesity (defined as BMI > 30kg/m²)
- Known pregnancy
- Contraindications for the placement of a nasogastric tube (upper airway/esophageal/gastric/mouth or face pathology (e.g. recent surgery, esophageal varices, diaphragmatic hernia), nasal bleeding within the last 2 weeks or use of anticoagulants)
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 |
|---|---|---|
| PEEP: 5 cmH2ODuring second part of the study (MRI) | Other | PEEP level of 5 cmH2O |
| PEEP: 10 cmH2ODuring second part of the study (MRI) | Other | PEEP level of 10 cmH2O |
| PEEP: 15 cmH2ODuring second part of the study (MRI) | Other | PEEP level of 15 cmH2O |
Primary outcome
Changes in diaphragm's position
Time frame: 2 hours
Changes in the position of the diaphragm during different PEEP levels, as measured with both ultrasound and MRI
Changes in diaphragm's shape and length
Time frame: 2 hours
Changes of the diaphragm's shape and length during different PEEP levels, as measured with MRI
Changes in diaphragm's efficiency
Time frame: 2 hours
Changes in the neuro-mechanical efficiency of the diaphragm (ratio between pressure and electrical muscle activity) during different PEEP levels, as measured with a nasogastric catheter
Change in twitch transdiaphragmatic pressures
Time frame: 2 hours
Twitch transdiaphragmatic pressures during different PEEP levels, as measured with magnetic stimulation of the phrenic nerves.
1 secondary outcome
Difference between MRI and ultrasound
Time frame: 2 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.
- 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 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 PEEP: 5 cmH2O, PEEP: 10 cmH2O and PEEP: 15 cmH2O in people with Diaphragm Disease, 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 7 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?
Changes in diaphragm's position (time frame: 2 hours). The study lists 4 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 20 May 2020.