Respiratory FailureNCT02936908
Respiratory Care in Intensive Care Unit for Neuromuscular Patients
An observational study of Respiratory Failure, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support. Research of markers associated with long term mortality and ventilatory status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Ventilatory support
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- Aug 2016to Oct 2017
- 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: Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles. Neuromuscular diseases concerned : Central or Peripheral metabolic, toxic, or inflammatory neuropathies, Central or peripheral neurodegenerative or hereditary disorders Myopathies, amongst them dystrophinopathies, myotonic dystrophies Myasthenia gravis Tetraplegy, consequence of cervical spinal cord injury
Who may be able to join
- Patient > 18 years old
- First stay in a ICU ward
- Inclusion period : Admission in ICU between 01/01/2007 and 31/12/2015
- Presenting an acute respiratory distress at admission or during ICU stay
- Diagnosis of neuromuscular disease confirmed before Hospital discharge
Who cannot join
- Absence of respiratory failure during ICU stay (ICU stay for monitoring or for a specialized invasive procedure in the absence of respiratory failure, for example)
- Neuromuscular disease not proven or uncertain diagnosis
- Anterior admission in ICU ward for vital organ failure
Trial locations and contacts
4 sites in 1 country.
Claude Guerin, PU-PH contact
France4 sites, 4 recruiting
- Recruiting
CHU Clermont Ferrand
Clermont-Ferrand
- Recruiting
CHU Grenoble
Grenoble
- Recruiting
Hôpital de la Croix Rousse
Lyon
Claude Guerin, 4 26 10 94 18 ext. +33, claude.guerin@chu-lyon.fr
- Recruiting
Hôpital Nord CHU St Etienne
Saint-Etienne
About this study
Official title: Modalities of Respiratory Care, Vital and Respiratory Prognosis in Neuromuscular Patients Admitted to an Intensive Care Unit for Respiratory Failure
Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support.
Research of markers associated with long term mortality and ventilatory status.
- Conditions
- Respiratory Failure
- Being tested
- Ventilatory support
- Keywords
- Neuromuscular Diseases, Muscular dystrophy, Amyotrophic Lateral Sclerosis, Acute respiratory failure, respiratory care, mechanical ventilation, weaning, Intensive Care Unit, Critical Care, Survival
- Medical subject headings
- Respiratory Insufficiency, Neuromuscular Diseases, Muscular Dystrophies, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilatory supportOther
Initiation of mechanical ventilatory support, invasive or non-invasive, Or modification of mechanical ventilatory support (modification of the parameters of the device, change of material, switch from non-invasive to invasive)
| Study group | Role | What they receive |
|---|---|---|
| Ventilatory support | Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles Receives: Other: Ventilatory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
number of death
Measured: until 2016.12.31
Secondary outcomes (3)
Definitive long term invasive ventilatory support
Date of tracheotomy for definitive long term invasive ventilatory support
Measured: until 2016.12.31
Mortality attributable to a respiratory issue
For patients for which this information is available, cause of death described as reliable to a respiratory issue in any medical document available.
Measured: until 2016.12.31
Re-hospitalization in a ICU-Ward
clinical deterioration requiring a new hospitalization in a ICU ward, after first hospitalization discharge.
Measured: until 2016.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936908
- Sponsor's protocol ID
- 69HCL16_0558
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modalities of Respiratory Care, Vital and Respiratory Prognosis in Neuromuscular Patients Admitted to an Intensive Care Unit for Respiratory Failure
- ClinicalTrials.gov ID
- NCT02936908
- Acronym / sponsor ID
- 69HCL16_0558
- Conditions
- Respiratory Failure
- Keywords
- Neuromuscular Diseases, Muscular dystrophy, Amyotrophic Lateral Sclerosis, Acute respiratory failure, respiratory care, mechanical ventilation, weaning, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Oct 2016 (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.
Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support.
Research of markers associated with long term mortality and ventilatory status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilatory support | – | Other: Ventilatory supportAdult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles. Neuromuscular diseases concerned : Central or Peripheral metabolic, toxic, or inflammatory neuropathies, Central or peripheral neurodegenerative or hereditary disorders Myopathies, amongst them dystrophinopathies, myotonic dystrophies Myasthenia gravis Tetraplegy, consequence of cervical spinal cord injury
Key inclusion criteria (5 listed)
- Patient > 18 years old
- First stay in a ICU ward
- Inclusion period : Admission in ICU between 01/01/2007 and 31/12/2015
- Presenting an acute respiratory distress at admission or during ICU stay
- Diagnosis of neuromuscular disease confirmed before Hospital discharge
Key exclusion criteria (3 listed)
- Absence of respiratory failure during ICU stay (ICU stay for monitoring or for a specialized invasive procedure in the absence of respiratory failure, for example)
- Neuromuscular disease not proven or uncertain diagnosis
- Anterior admission in ICU ward for vital organ failure
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 |
|---|---|---|
| Ventilatory supportInitiation of mechanical ventilatory support, invasive or non-invasive, Or modification of mechanical ventilatory support (modification of the parameters of the device, change of material, switch from non-invasive to invasive) | Other | Ventilatory support |
Primary outcome
Mortality
Time frame: until 2016.12.31
number of death
3 secondary outcomes
Definitive long term invasive ventilatory support
Time frame: until 2016.12.31
Mortality attributable to a respiratory issue
Time frame: until 2016.12.31
Re-hospitalization in a ICU-Ward
Time frame: until 2016.12.31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Claude Guerin, PU-PH contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Hospices Civils de Lyon at 4 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Chabert (4 26 10 94 18 ext. +33, polchaber@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: until 2016.12.31). 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 29 Aug 2017.