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Pilot study on the influence of tracheal cuff status on breathing swallowing coordination and secretion

Pilot study on the influence of tracheal cuff status on breathing swallowing coordination and secretion - PITAS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034676
Enrollment
40
Registered
2025-01-03
Start date
2025-01-22
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

R13.1

Interventions

Group 1: The breathing-swallowing coordination and secretions are initially assessed with a cuffed tracheostomy tube. The patients will receive 2 ml, 5 ml and 10 ml of water for swallowing. Subsequent

Sponsors

Johanniter-Krankenhaus Stendal
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - legal age - tracheostomy tube with cuff and without subglottic suction - Tolerance for cuff deflation and occlusion of the tube for the duration of the examination and disconnection from ventilation if necessary - Swallowing of small amounts of purée or liquid possible - Recognizable “white out” in FEES

Exclusion criteria

Exclusion criteria: - Disconnection of ventilation not possible for the examination period - Pathological breathing patterns (e.g. Cheyne Stokes breathing) or paradoxical breathing - no declaration of consent

Design outcomes

Primary

MeasureTime frame
Changes of breathing-swallowing coordination (BSC) for the intake of 2 ml, 5 ml and 10 ml cooled water with the tracheostomy tube cuffed as well as uncuffed with a speaking valve. BSC will be evaluated using the white out and a breathing belt.

Secondary

MeasureTime frame
change in secretion (New Zealand Secretion Scale; Miles & Hunting, 2018)

Countries

Germany

Contacts

Public ContactSarah Bohe

BDH-Klinik Elzach

sarah.bohe@bdh-klinik-elzach.de+49 7682 801 - 4013

Outcome results

None listed

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