Evaluating swallowing function in patients with tracheostomy after head and neck surgery
THE IMPACT OF TRACHEAL TUBE ON SWALLOWING IN POST-OPERATIVE HEAD AND NECK CANCER PATIENTS: SCINTIGRAPHIC ANALYSIS
This study is trying to see how well people with tracheostomies can swallow after head and neck cancer surgery, to understand if keeping the tube in during swallowing therapy is safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05738421 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the swallowing function in tracheostomized patients who have undergone major oncological surgery for head and neck cancer. It will provide objective data on bolus transit during swallowing in patients with and without a tracheal tube, helping to determine the safety of preserving the tube during swallowing rehabilitation. The study will utilize fiberoptic endoscopic evaluation of swallowing to gather data on the swallowing features of these patients. By comparing the swallowing parameters, the study seeks to clarify the impact of tracheal tubes on dysphagia in this population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a specific tracheal tube size who can tolerate tube capping and have the ability to swallow according to the inpatient training program.
Not a fit: Patients with previous head and neck radiotherapy, total laryngectomy, or those unable to maintain an upright position may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve swallowing rehabilitation strategies for dysphagic patients after head and neck surgery.
How similar studies have performed: Previous studies have shown mixed results regarding the impact of tracheal tubes on swallowing, indicating that this approach may provide new insights into an area with conflicting literature.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- Maria Raffaella Marchese — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Jacopo Galli — Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma
- Study coordinator: Jacopo Galli
- Email: jacopo.galli@policlinicogemelli.it
- Phone: 3338356370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.