Study comparing long-term measurement of swallowing with endoscopic swallowing examination in the context of tracheostomy tube management in patients with dysphagia.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016952

Enrollment

100

Registered

2021-10-05

Start date

2019-09-12

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

Dysphagia

Interventions

Group 1: Fiberoptic endoskopic evaluation of swallowing (FEES)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy patients as comparison group; patients with a swallowing disorder (diagnosis confirmation and severity assessment), patients with a tracheal cannula due to a swallowing disorder.

Exclusion criteria

Exclusion criteria: Children, Pregnancy

Design outcomes

Primary

Measure	Time frame
Prior to endoscopic swallowing examination (FEES) with the purpose of tracheal tube status change, a 2-4h long-term measurement is performed. The determined parameters (swallowing frequency, extension and speed of laryngeal elevation, swallowing duration, breathing) are compared with the decision for tracheal cannula status change and thus the measurement procedures are tested for correlation.	—

Secondary

Measure	Time frame
Healthy persons readings are setting the basis for the calculation of the percentiles for individual parameters. Patients with a positive decision for a tracheal tube status-change, will afterwards participate in a 1h long-term measurement to evaluate the result. By means of a chest strap, respiration will be recorded and breath-swallow patterns will be identified and analyzed. Strongly influencing criteria for a safe tracheal cannula management will be identified and evaluated. Furthermore, algorithms for swallow assessment will be developed to simplify decision making in clinical practice and thus improve the quality of life of patients.	—

Measure

Time frame

Healthy persons readings are setting the basis for the calculation of the percentiles for individual parameters. Patients with a positive decision for a tracheal tube status-change, will afterwards participate in a 1h long-term measurement to evaluate the result. By means of a chest strap, respiration will be recorded and breath-swallow patterns will be identified and analyzed. Strongly influencing criteria for a safe tracheal cannula management will be identified and evaluated. Furthermore, algorithms for swallow assessment will be developed to simplify decision making in clinical practice and thus improve the quality of life of patients.

—

Countries

Germany

Contacts

Public ContactRainer Seidl

Klinik für Hals- Nasen-, Ohren- Krankheiten Unfallkrankenhaus Berlin

rainer.seidl@ukb.de030 5681 4301

Outcome results

None listed

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