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Prospective randomized controlled study on the influence of closed vs open tracheostomy tubes on swallowing in patients with neurogenic dysphagia

Prospective randomized controlled study on the influence of closed vs open tracheostomy tubes on swallowing in patients with neurogenic dysphagia - manometry/ cap

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003060
Enrollment
40
Registered
2011-05-13
Start date
2011-05-16
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

R13.0

Interventions

Group 1: 20 tracheotomized patients suffering from dysphagia after a single monohemispheric lesion. 1st phase: respiration via nose/ mouth
2nd phase: respiration via tracheostomy tube Group 2: 20 tracheotomized patients suffering from dysphagia after a single monohemispheric lesion. 1st phase: respiration via tracheostomy tube
2nd phase: respiration via nose/ mouth

Sponsors

Schoen Klinik Bad Ailbing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - neurogenic dysphagia [clinical signs: modified Evan´s Blue Dye test (Belafsky et al., 2003); De-Pippo-water test (Suiter & Leder, 2008)] - monohemispheric lesions - patients will be included consecutively - no previous neurologic or relevant anatomic morphologic lesions - no peripheral (2nm MN) vocal cord paralysis - effective reflectory cough - trach tube can be uncuffed for 10 minutes without relevant SPO2 decrease - no oropharyngeal tumors -no previous surgery (aero-digestive tract)

Exclusion criteria

Exclusion criteria: - no written consent - severe not substitutable coagulation deficits - esophageal diverticulum - respiratory insufficiency (SaO2<90%) - bradycardia (<50/min)

Design outcomes

Primary

MeasureTime frame
Manometric pressure differences (between base of tongue and pharyngeal wall) during swallowing method: pharyngeal manometry measurement points: oropharynx, hypopharynx, upper esophageal sphincter data points: maximal pressure, duration of pressure

Secondary

MeasureTime frame
degrees of aspiration (Penetration-Aspiration Scale, Rosenbek et al., 1996); data extraction: simultaneous manometric and endoscopic measurement during swallowing (puree)

Countries

Germany

Contacts

Public ContactChristian Ledl

Schoen Klinik Bad Aibling

cledl@schoen-kliniken.de+49 (0) 8061 903 1583

Outcome results

None listed

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