ICU Acquired Neuromyopathy and Diaphragm Function

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).

Study Overview

• Status: Completed
• Conditions: Critical Illness Myopathy; Respiratory Paralysis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Department of Anesthesiology & Critical Care, St Eloi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients acquired weakness and neuromyopathy in ICU

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At the begining of the spontaneous breathing trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation success (defined as no need reintubation during the 48h after extubation)	Participants will be followed until Day 28 after ICU admission.	Day 28 after ICU admission

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Samir Jaber, MD PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Ultrasound; Weaning; Mechanical ventilation; Critical illness neuromyopathy; Diaphragm dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Disease Attributes; Respiratory Insufficiency; Critical Illness; Paralysis; Neuromuscular Diseases; Respiratory Paralysis
• Other Study ID Numbers: 9163