Effect of standardized thickened liquids (IDDSI Level 1) on aspiration in patients with CIP/CIM-associated neurological dysphagia: a randomised controlled trial (RCT)

Phase 4

Conditions: R13.0
G72.80

Registration Number: DRKS00024397

Lead Sponsor: Schön KLinik Bad Aibling

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients with CIP/CIM associated neurological dysphagia; Patients with and without tracheotomy; penetration/aspiration score = 4 for regular water (IDDSI 0) during FEES; age = 50; consent to participate in RCT; consent to undergo FEES

Exclusion Criteria

missing consent to participate in trial (to undergo FEES respectively); oro-pharyngeal-esophageal tumors or scarring; severe non-substitutable coagulation defects; persisting ventilatory assistance; non compensable impaiments of mouth opening

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is the Degree of aspiration -measured by the Penetration-Aspiration scale (Rosenbek et al. 1998)- when swallowing water in comparison to swallowing standardized thickened liquids (IDDSI level 1). The degree of penetration/aspiration is expected to be lower when swallowing standardized thickened (IDDSI 1) water than with regular water (IDDSI 0). H0: PA level of thickened water (IDDSI 1) is higher or equal than the PA level of regular water (IDDSI 0). H1: PA level of thickened water (IDDSI 1) is lower than the PA level of regular water (IDDSI 0).

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is the degree of pharyngeal residuals in the valleculae and sinus piriformes for standardized thickened water (IDDSI 1) and regular water (IDDSI 0) respectively. The Yale Pharyngeal Residual Rating Scale (Yale Scale) is the underlying measure to determine the severity of pharyngeal residue. A higher degree of pharyngeal residue is assumed when swallowing thickend water. Ho: The Yale rating for thickened water (IDDSI 1) is lower or equal than the rating for regular water (IDDSI 0). H1: The Yale rating for thickened water (IDDSI 1) is higher than the rating for regular water (IDDSI 0).