ICU Acquired Neuromyopathy and Diaphragm Function

NCT01968889 | Completed DMC

• 1 other identifier: 9163
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness Myopathy; Respiratory Paralysis

Keywords

Critical illness neuromyopathy; Diaphragm dysfunction; Mechanical ventilation; Weaning; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• extubation success (defined as no need reintubation during the 48h after extubation)

  Day 28 after ICU admission

Study Arms (1)

Critical illness neuromyopthy

Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion

Other: Non invasive phrenic nerve stimulation

Interventions

Non invasive phrenic nerve stimulation OTHER

Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion

Critical illness neuromyopthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients acquired weakness and neuromyopathy in ICU

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Anesthesiology & Critical Care, St Eloi University

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir Jaber, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: October 24, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

FR (1)