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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024397

Enrollment

Registered

2021-03-02

Start date

2021-03-04

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

R13.0 G72.80

Interventions

Group 1: Study Group: Application of standardized thickened liquids IDDSI level 1 (3 swallows of 5ml) during FEES Group 2: Sham Group: Application of non-thickened liquids IDDSI level 0 (3 swallows of

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Germany

Contacts

Public ContactWolfgang Klein

Schön Klinik Bad Aibling

wklein@schoen-klinik.de08061- 903- 51532

Outcome results

None listed

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