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ICU Acquired Neuromyopathy and Diaphragm Function

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ClinicalTrials.gov Identifier: NCT01968889
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

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).

Condition or disease Intervention/treatment
Critical Illness Myopathy Respiratory Paralysis Other: Non invasive phrenic nerve stimulation

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

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)
Study Start Date : May 2013
Primary Completion Date : November 2013
Study Completion Date : November 2013

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Critical illness neuromyopthy
Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion
Other: Non invasive phrenic nerve stimulation
Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion

Outcome Measures

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. extubation success (defined as no need reintubation during the 48h after extubation) [ Time Frame: Day 28 after ICU admission ]
    Participants will be followed until Day 28 after ICU admission.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients acquired weakness and neuromyopathy in ICU

Inclusion Criteria:

  • MRC score <48
  • ready for weaning from mechanical ventilation

Exclusion Criteria:

  • previous history of neuromyopathy
  • impossibility to perform a magnetic stimulation
  • cervical spine injury
  • bihemispheric or brain stem lesion
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968889

Department of Anesthesiology & Critical Care, St Eloi University
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Samir Jaber, MD PhD University Hospital, Montpellier
More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01968889     History of Changes
Other Study ID Numbers: 9163
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Montpellier:
Critical illness neuromyopathy
Diaphragm dysfunction
Mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Neuromuscular Diseases
Respiratory Paralysis
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases