ICU Acquired Neuromyopathy and Diaphragm Function

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01968889

Collaborator

(none)

Enrollment

Location

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Myopathy Respiratory Paralysis	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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

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)

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Twitch tracheal pressure during airway occlusion (expressed in cmH2O) [At the begining of the spontaneous breathing trial]
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) [Day 28 after ICU admission]
Participants will be followed until Day 28 after ICU admission.