Ireland
--:--IST
Latest
Clinical Trials in Italy / NCT05738421
Recruiting Observational

Tracheal Tube and Swallowing After Head and Neck Surgery

NCT05738421 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-12-06
Last updated
2024-10-04

Condition(s) studied

Dysphagia

Investigational drug(s) / intervention(s)

fiberoptic endoscopic evaluation of swallowing

fiberoptic endoscopic evaluation of swallowing: Questionnaire, FEES, OPES

Study summary

The present study was designed as a cross-sectional observational study providing the enrollment of tracheostomized patients undergoing major oncological surgery for head-neck cancer.

Aims:

* to provide objective data on the bolus transit during swallowing in tracheostomized patients with tracheal tube and without tracheal tube closing directly the tracheal stoma with a plaster, in order to sustain the choice to preserve the TT in dysphagic patients after oncologic surgery for more security during swallowing rehabilitation or adjuvant treatment.
* to evaluate the features of swallowing, specifically bolus transit, in patients affected by head and neck cancer who underwent major oncological surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion criteria * Age \>18 years * Tracheal tube diameter of 5.0 mm and outside diameter of 9.4 mm * Tolerance of the tracheal tube capping for almost 48 hours without pathologic desaturation during continue monitoring of SpO2 * Ability to swallow in accordance to the inpatient training program * Ability to suck with a straw without oral leakage Exclusion criteria * Previous head and neck radiotherapy * Patients with nasal tube feeding * Patients with poor cognition or poor general condition or affected by neurological o other nontumor-related dysphagia * Patients total laryngectomized * Patients unable to maintain the orthostatic position

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Maria Raffaella Marchese Roma Italy Recruiting

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05738421 on ClinicalTrials.gov ↗ ← All trials in Italy