ICU Acquired Neuromyopathy and Diaphragm Function

Critical Illness Myopathy Clinical Trial

Official title:

Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968889
• Other study ID #: 9163
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: December 2, 2014
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Myopathy
• Neuromuscular Diseases
• Respiratory Paralysis

Intervention

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

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, St Eloi University	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No