Clinical trial NCT01968889: ICU Acquired Neuromyopathy and Diaphragm Function
Official title: Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness Myopathy
Respiratory Paralysis
Keywords: Critical illness neuromyopathy
Diaphragm dysfunction
Mechanical ventilation
Weaning
Ultrasound
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients acquired weakness and neuromyopathy in ICU

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Twitch tracheal pressure during airway occlusion (expressed in cmH2O)
timeFrame: At the begining of the spontaneous breathing trial
Secondary outcomes:
measure: extubation success (defined as no need reintubation during the 48h after extubation)
timeFrame: Day 28 after ICU admission
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesiology & Critical Care, St Eloi University
Study officials:
affiliation: University Hospital, Montpellier
name: Samir Jaber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: