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

Neurological Sequelae of Sepsis: Chronic dysphagia in patients with critical illness polyneuropathy (CIP) or myopathy (CIM) - NeuroSOS-DYSPHAGIA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00000650

Enrollment

150

Registered

2011-01-31

Start date

2011-02-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9 G62.8 R13.9

Interventions

Group 1: After 2 weeks patients will be examined using fiberoptic endoscopic evaluation of swallowing (FEES) and they will be scored according to the Penetration Aspiration Scale (PAS). Thereby we ass

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Dysphagia at T2 defined as FEES PAS score > 4	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactOrlando Guntinas-Lichius

HNO-Klinik Universität Jena

orlando.guntinas@med.uni-jena.de03641-935127

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026