Critically IllNCT00786526
Diaphragmatic Function in Ventilated Patients
An observational study of Critically Ill, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critically Ill
- How many people
- 55 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2008to Jul 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intubated patients in intensive care unit
Who may be able to join
- Invasive mechanical ventilation (tracheally intubated or tracheotomized) less than 48h.·
- Duration of mechanical ventilation for at least 72h.·
- Subject itself or its next of kin has given written informed consent
Who cannot join
- Patient is less than 18 years or more than 85 years of age·
- The attending physician refuses to allow enrollment·
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent·
- Pregnant or breast-feeding female.
- A pregnancy test will be performed in all female patients less than 60 years of age.·
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- Any contraindication to use cervical magnetic stimulation (mechanical cardiac assist device …).·
- Presence or suspicion of prior diaphragm injury or chronic disease·
- Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Pneumologie et Réanimation
Groupe Hospitalier La Pitié-Salpêtrière-Paris, Paris, 75013
Department of Anesthesia and Critical Care (DAR B)
Saint-Eloi University Hospital of Montpellier, Montpellier, 34295
About this study
Official title: Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients
Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).
- Conditions
- Critically Ill
- Keywords
- Mechanical ventilation, Ventilator induced diaphragmatic dysfunction, Weaning, Neuromuscular diseases- Respiratory function tests, Intubated patients in intensive care unit
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function parameters
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionJul 2010
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 Critically IllStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas SIMILOWSKI, MD, PhD, Study chair, Groupe Hospitalier La Pitié-Salpêtrière-Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786526
- Sponsor's protocol ID
- UF7854
- Status last verified
- Oct 2013
- First submitted
- 5 Nov 2008
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.
PubMed 27492005Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
PubMed 23641946
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00786526
- Acronym / sponsor ID
- UF7854
- Conditions
- Critically Ill
- Keywords
- Mechanical ventilation, Ventilator induced diaphragmatic dysfunction, Weaning, Neuromuscular diseases- Respiratory function tests, Intubated patients in intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Nov 2008 (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.
Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated patients in intensive care unit
Key inclusion criteria (3 listed)
- Invasive mechanical ventilation (tracheally intubated or tracheotomized) less than 48h.·
- Duration of mechanical ventilation for at least 72h.·
- Subject itself or its next of kin has given written informed consent
Key exclusion criteria (9 listed)
- Patient is less than 18 years or more than 85 years of age·
- The attending physician refuses to allow enrollment·
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent·
- Pregnant or breast-feeding female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory function parameters
Time frame: 6 weeks
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 30 Oct 2013.
- Derived from this study: PubMed 27492005Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.
- Derived from this study: PubMed 23641946Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
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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.
Thomas SIMILOWSKI, MD, PhD study chair
Groupe Hospitalier La Pitié-Salpêtrière-Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by University Hospital, Montpellier at 2 sites in France.
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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Respiratory function parameters (time frame: 6 weeks). 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 NCT00786526, 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 30 Oct 2013.