Neurophysiological Diagnosis for ICU Septic Shock Patients

NCT ID: NCT03802500

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-23
• Study Completion Date: 2019-12-31

Brief Summary

Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors.

ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness.

The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.

Conditions

ICU Acquired Weakness

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Nerve conduction study

Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally.

Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM).

The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU.

PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is < 2,5 mV.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Peroneal nerve test (PENT test)

Eligibility Criteria

Inclusion Criteria

• Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.

Exclusion Criteria

• Hospitalization for more than 7 days before intubation.
• Functional disability at admission of ≥4 (Requires constant nursing care and attention, bedridden, incontinent) in the Modified Rankin Scale.
• Lower limb disorders precluding nerve conduction studies (NCV) and electromyography (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs.
• Evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease.
• Burn patients admitted to ICU.
• Patient requesting withdrawal of therapies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

CAROLINE ATTWELL

Mrs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Diserens, PD-MER

Role: STUDY_DIRECTOR

NRA Unit. CHUV.

Locations

CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

CAROLINE ATTWELL

Role: CONTACT

caroline.attwell@chuv.ch

0789242320

Facility Contacts

CAROLINE ATTWELL

Role: primary

caroline.attwell@chuv.ch

0795567994

Other Identifiers

NRA-01

Identifier Type: -

Identifier Source: org_study_id