Ventilator-induced Diaphragm DysfunctionITAVIDDNCT02299986
An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction
An observational study of Ventilator-induced Diaphragm Dysfunction and VIDD, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical ventilation and respiratory muscle unloading on the diaphragm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-induced Diaphragm Dysfunction, VIDD
- What is being tested?
- Ultrasound measurement
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Jun 2015
- Phase
- Observational
- 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
Study population: All patients that are admitted in ICU and who require mechanical ventilation will be screened for inclusion, and participants will be enrolled after informed consent. The study population will be a mixed medical/surgical cohort, selected with non-probability sampling because of the different eligibility criteria.
Who may be able to join
- The patient must suffer from respiratory insufficiency requiring mechanical ventilation
Who cannot join
- The patient has been hospitalized and mechanically ventilated (invasive or non- invasive) in the period up to 1 year before start of the study.
- The patient is known or suspected to have an anatomical malformation of the diaphragm.
- The patient suffers from a disease that may impair diaphragmatic function:
- Central neural disease at the level of the brain (Multiple sclerosis, stroke, Arnold-Chiari malformation) and spinal cord (quadriplegia, amyotrophic lateral sclerosis, poliomyelitis, spinal muscular atrophy, syringomyelia).
- Neural disease of the phrenic nerve (Guillain-Barré syndrome, tumor compression, neuralgic neuropathy, chronic inflammatory demyelinating polyneuropathy, Charcot-Marie-Tooth disease).
- Disorders of the neuromuscular junction (Myasthenia gravis, Lambert- Eaton syndrome, botulism, organophosphate poisoning).
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- Muscular diseases (muscular dystrophies, myositis (infectious, inflammatory, metabolic).
- The patient is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained results.
- The patient has been mechanically ventilated for over 24 hours before the first ultrasonographic measurement can be performed.
Trial locations and contacts
1 site in 1 country.
About this study
'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre, observational cohort study to examine the long-term effects of invasive mechanical ventilation on the diaphragm, and to study the risk factors associated with VIDD.
- Conditions
- Ventilator-induced Diaphragm Dysfunction, VIDD
- Being tested
- Ultrasound measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurementOther
Thickness measurement through ultrasound. The investigators will perform daily ultrasound measurements to assess the evolution in thickness during mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Single arm Ultrasound measurement | Ultrasound measurement Receives: Other: Ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaphragm thickness
Measured: Participants will be followed during their ICU stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator-induced Diaphragm DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Schepens, MD, University Hospital, Antwerp
- Investigators
- Tom Schepens, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299986
- Sponsor's protocol ID
- EC 13/12/131
- Other IDs
- B300201317057
- Acronym
- ITAVIDD
- Status last verified
- Jun 2015
- First submitted
- 10 Nov 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.
PubMed 23364680Schepens T, Verbrugghe W, Dams K, Corthouts B, Parizel PM, Jorens PG. The course of diaphragm atrophy in ventilated patients assessed with ultrasound: a longitudinal cohort study. Crit Care. 2015 Dec 7;19:422. doi: 10.1186/s13054-015-1141-0.
PubMed 26639081
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An InnovaTive Approach to Ventilator-Induced Diaphragmatic Dysfunction
- ClinicalTrials.gov ID
- NCT02299986
- Acronym / sponsor ID
- ITAVIDD / EC 13/12/131
- Conditions
- Ventilator-induced Diaphragm Dysfunction, VIDD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Nov 2014 (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.
'Ventilator-Induced Diaphragmatic Dysfunction (VIDD) was originally described by Vassilakopoulos and Petrof in 1998, where it is used to cover the effects of mechanical ventilation and respiratory muscle unloading on the diaphragm. A recent article by Grosu and colleagues has demonstrated that the thickness of the diaphragm decreases with about 6% a day in a small cohort of mechanically ventilated patients. This is a longitudinal, single-centre, observational cohort study to examine the long-term effects of invasive mechanical ventilation on the diaphragm, and to study the risk factors associated with VIDD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm Ultrasound measurement | – | Other: Ultrasound measurementUltrasound measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are admitted in ICU and who require mechanical ventilation will be screened for inclusion, and participants will be enrolled after informed consent. The study population will be a mixed medical/surgical cohort, selected with non-probability sampling because of the different eligibility criteria.
Key inclusion criteria (1 listed)
- The patient must suffer from respiratory insufficiency requiring mechanical ventilation
Key exclusion criteria (9 listed)
- The patient has been hospitalized and mechanically ventilated (invasive or non- invasive) in the period up to 1 year before start of the study.
- The patient is known or suspected to have an anatomical malformation of the diaphragm.
- The patient suffers from a disease that may impair diaphragmatic function:
- The patient is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained results.
- The patient has been mechanically ventilated for over 24 hours before the first ultrasonographic measurement can be performed.
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 |
|---|---|---|
| Ultrasound measurementThickness measurement through ultrasound. The investigators will perform daily ultrasound measurements to assess the evolution in thickness during mechanical ventilation | Other | Single arm Ultrasound measurement |
Primary outcome
Change in diaphragm thickness
Time frame: Participants will be followed during their ICU stay, an expected average of 1 week
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 24 Jun 2015.
- Background: PubMed 23364680Grosu HB, Lee YI, Lee J, Eden E, Eikermann M, Rose KM. Diaphragm muscle thinning in patients who are mechanically ventilated. Chest. 2012 Dec;142(6):1455-1460. doi: 10.1378/chest.11-1638.
- Derived from this study: PubMed 26639081Schepens T, Verbrugghe W, Dams K, Corthouts B, Parizel PM, Jorens PG. The course of diaphragm atrophy in ventilated patients assessed with ultrasound: a longitudinal cohort study. Crit Care. 2015 Dec 7;19:422. doi: 10.1186/s13054-015-1141-0.
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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.
Tom Schepens, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-induced Diaphragm Dysfunction and VIDD, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 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 24 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 Belgium. 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 diaphragm thickness (time frame: Participants will be followed during their ICU stay, an expected average of 1 week). 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 NCT02299986, which also lists 2 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 24 Jun 2015; AzTrials last refreshed its copy on 30 Oct 2026.