ICU Acquired Neuromyopathy and Diaphragm Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01968889
First received: August 19, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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 Intervention
Critical Illness Myopathy
Respiratory Paralysis
Other: Non invasive phrenic nerve stimulation

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Twitch tracheal pressure during airway occlusion (expressed in cmH2O) [ Time Frame: At the begining of the spontaneous breathing trial ] [ Designated as safety issue: No ]
    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:
  • extubation success (defined as no need reintubation during the 48h after extubation) [ Time Frame: Day 28 after ICU admission ] [ Designated as safety issue: No ]
    Participants will be followed until Day 28 after ICU admission.


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients acquired weakness and neuromyopathy in ICU

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968889

Contacts
Contact: Samir Jaber, MD PhD +33 4 67 33 72 71 s-jaber@chu-montpellier.fr

Locations
France
Department of Anesthesiology & Critical Care, St Eloi University Recruiting
Montpellier, France, 34000
Contact: Samir Jaber, MD PhD    + 33 4 67 33 72 71    s-jaber@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Samir Jaber, MD PhD University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01968889     History of Changes
Other Study ID Numbers: 9163
Study First Received: August 19, 2013
Last Updated: October 18, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on September 22, 2014