Tracheal Tube and Swallowing After Head and Neck Surgery

NCT05738421 | Recruiting

• 1 other identifier: 4459
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• To provide objective data on the bolus transit during swallowing in tracheostomized patients with tracheal tube and without tracheal tube

  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.

  five years

Secondary Outcomes (1)

• To evaluate the features of swallowing

  five years

Interventions

fiberoptic endoscopic evaluation of swallowing DIAGNOSTIC_TEST

Questionnaire, FEES, OPES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this study, a total of 20 tracheostomized patients undergoing primary major surgery for head and neck cancer will be enrolled at the Otolaryngology hospitalization department of the Fondazione Policlinico Univesitario A. Gemelli, in Rome (Italy)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Maria Raffaella Marchese

Roma, 00198, Italy

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jacopo Galli

  Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacopo Galli

CONTACT

3338356370; jacopo.galli@policlinicogemelli.it

Maria Raffaella Marchese

CONTACT

3391144556; raffaellamarchese@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Director of Otorhinolaryngology Unit

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 22, 2023
• Study Start: December 6, 2021
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)