Diaphragmatic Function in Ventilated Patients

NCT ID: NCT00786526

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mechanical ventilation Ventilator induced diaphragmatic dysfunction Weaning Neuromuscular diseases- Respiratory function tests Intubated patients in intensive care unit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.·
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas SIMILOWSKI, MD, PhD

Role: STUDY_CHAIR

Groupe Hospitalier La Pitié-Salpêtrière-Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesia and Critical Care (DAR B)

Saint-Eloi University Hospital of Montpellier, Montpellier, France

Site Status

Service de Pneumologie et Réanimation

Groupe Hospitalier La Pitié-Salpêtrière-Paris, Paris, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27492005 (View on PubMed)

Demoule 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.

Reference Type DERIVED
PMID: 23641946 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UF7854

Identifier Type: -

Identifier Source: org_study_id