eurological Sequelae of Sepsis: Chronic dysphagia in patients with critical illness polyneuropathy (CIP) or myopathy (CIM)

• Conditions: A41.9; G62.8; R13.9; Sepsis, unspecified; Other specified polyneuropathies

• Registration Number: DRKS00000650
• Lead Sponsor: HNO-KlinikUniversität Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• Study Completion: 2013-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients with severe sepsis and/or septic shock according to the ACCP/SCCM

Exclusion Criteria

Patient has a history of diseases with high risk for polyneuropathia/myopathia: neuromuscular disorders, diabetes mellitus, alcohol abuse, steroid therapy due to asthma, COPD, etc.; patient is likely to die within less than 24 hours.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dysphagia at T2 defined as FEES PAS score > 4

Secondary Outcome Measures

Name	Time	Method
The secondary outcome are the endoscopic evaluation of swallowing (FEES) and the score according to the Penetration Aspiration Scale (PAS) after 2 weeks and 4 months. Additionally, all patients with a PAS score >1 will be subject to videofluoroscopy. Moreover, patients will be scored according to the Functional Oral Intake Scale after 2 weeks and after 4 months. Further swallowing- and nutrition-related parameters, such as aspiration of saliva, tongue movement, vocal cord mobility, and pneumonia, CIP/CIM as an independent risk factor for the development of chronic dysphagia defined by a FEES penetration-aspiration score > 4 at T2 in septic patients will be assessed as well.