NCT05738421 Tracheal Tube and Swallowing After Head and Neck Surgery
| NCT ID | NCT05738421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Dysphagia |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-12-06 |
| Primary Completion | 2026-10-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2021-12-06 with a primary completion date of 2026-10-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jacopo Galli
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma
Frequently Asked Questions
Who can join the NCT05738421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05738421 currently recruiting?
Yes, NCT05738421 is actively recruiting participants. Contact the research team at jacopo.galli@policlinicogemelli.it for enrollment information.
Where is the NCT05738421 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05738421 clinical trial?
NCT05738421 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Jacopo Galli at Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma. The trial plans to enroll 30 participants.