Critical Illness MyopathyNCT01968889
ICU Acquired Neuromyopathy and Diaphragm Function
An observational study of Critical Illness Myopathy and Respiratory Paralysis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Myopathy, Respiratory Paralysis
- What is being tested?
- Non invasive phrenic nerve stimulation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Nov 2013
- 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: patients acquired weakness and neuromyopathy in ICU
Who may be able to join
- MRC score <48
- ready for weaning from mechanical ventilation
Who cannot join
- previous history of neuromyopathy
- impossibility to perform a magnetic stimulation
- cervical spine injury
- bihemispheric or brain stem lesion
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology & Critical Care, St Eloi University
Montpellier, 34000
About this study
Official title: Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)
Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation.
The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score < 48).
The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).
Read the detailed description
Diaphragm function will be assessed through phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion (expressed in cmH2O). It will be assessed during a spontaneous breathing trial for each patient with a known critical illness neuromyopathy. The diaphragm (thickness and course) will be studied by ultrasound assessment as well. Peripheral limbs force will be evaluated by the MRC score. A total of 40 analysable patients will be included.
All these measurements will be made at the time of the spontaneous breathing trial (SBT) during the weaning phase. No modification of the clinical practices of the care should be modified by the study. The twitch airway pressure during airway occlusion will be assessed at the begining of the SBT. The other measurements will be performed 30 mn after the SBT if this one will be well tolerated.
Participants will be followed for the duration of ICU stay.
- Conditions
- Critical Illness Myopathy, Respiratory Paralysis
- Being tested
- Non invasive phrenic nerve stimulation
- Keywords
- Critical illness neuromyopathy, Diaphragm dysfunction, Mechanical ventilation, Weaning, Ultrasound
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive phrenic nerve stimulationOther
Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion
| Study group | Role | What they receive |
|---|---|---|
| Critical illness neuromyopthy | Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion Receives: Other: Non invasive phrenic nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twitch tracheal pressure during airway occlusion (expressed in cmH2O)
According the standard of care of weaning process; to evaluate the readiness of the patient to be extubated, the setting of the ventilator should be set at 7 cmH20 PRESSURE SUPPORT VENTILATION (PSV) level and zero end expiratory pressure (PEEP=0) during spontaneous mechanical ventilation to mimic the spontaneous breathing trial (SBT).
Measured: At the begining of the spontaneous breathing trial
Secondary outcomes (1)
extubation success (defined as no need reintubation during the 48h after extubation)
Participants will be followed until Day 28 after ICU admission.
Measured: Day 28 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness MyopathyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jaber, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968889
- Sponsor's protocol ID
- 9163
- Status last verified
- Dec 2014
- First submitted
- 19 Aug 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)
- ClinicalTrials.gov ID
- NCT01968889
- Acronym / sponsor ID
- 9163
- Conditions
- Critical Illness Myopathy, Respiratory Paralysis
- Keywords
- Critical illness neuromyopathy, Diaphragm dysfunction, Mechanical ventilation, Weaning, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Oct 2013 (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.
Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation.
The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score < 48).
The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).
Detailed description
Diaphragm function will be assessed through phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion (expressed in cmH2O). It will be assessed during a spontaneous breathing trial for each patient with a known critical illness neuromyopathy. The diaphragm (thickness and course) will be studied by ultrasound assessment as well. Peripheral limbs force will be evaluated by the MRC score. A total of 40 analysable patients will be included.
All these measurements will be made at the time of the spontaneous breathing trial (SBT) during the weaning phase. No modification of the clinical practices of the care should be modified by the study. The twitch airway pressure during airway occlusion will be assessed at the begining of the SBT. The other measurements will be performed 30 mn after the SBT if this one will be well tolerated.
Participants will be followed for the duration of ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical illness neuromyopthy | – | Other: Non invasive phrenic nerve stimulationNon invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients acquired weakness and neuromyopathy in ICU
Key inclusion criteria (2 listed)
- MRC score <48
- ready for weaning from mechanical ventilation
Key exclusion criteria (4 listed)
- previous history of neuromyopathy
- impossibility to perform a magnetic stimulation
- cervical spine injury
- bihemispheric or brain stem lesion
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 |
|---|---|---|
| Non invasive phrenic nerve stimulationNon invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion | Other | Critical illness neuromyopthy |
Primary outcome
Twitch tracheal pressure during airway occlusion (expressed in cmH2O)
Time frame: At the begining of the spontaneous breathing trial
According the standard of care of weaning process; to evaluate the readiness of the patient to be extubated, the setting of the ventilator should be set at 7 cmH20 PRESSURE SUPPORT VENTILATION (PSV) level and zero end expiratory pressure (PEEP=0) during spontaneous mechanical ventilation to mimic the spontaneous breathing trial (SBT).
1 secondary outcome
extubation success (defined as no need reintubation during the 48h after extubation)
Time frame: Day 28 after ICU admission
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 3 Dec 2014.
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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.
Samir Jaber, MD PhD principal investigator
University Hospital, Montpellier
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 Critical Illness Myopathy and Respiratory Paralysis, run by University Hospital, Montpellier at 1 site 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 2 inclusion and 4 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 3 Dec 2014. 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 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?
Twitch tracheal pressure during airway occlusion (expressed in cmH2O) (time frame: At the begining of the spontaneous breathing trial). 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 3 Dec 2014.