Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05738421 |
| Other study ID # |
4459 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 6, 2021 |
| Est. completion date |
October 6, 2026 |
Study information
| Verified date |
February 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Jacopo Galli |
| Phone |
3338356370 |
| Email |
jacopo.galli[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
In the last twenty years, a wide and conflicting literature discussed about the impact of the
presence of a tracheal tube (TT), even if occluded, on the swallowing function. Early the
majority of authors agreed to target the tracheal tube as the cause of aspiration basing on
several mechanisms, first of all the decrease of laryngeal elevation. Nevertheless over time,
new researches had open to different results. In 2010 Leder et al. [1] demonstrated the
absence of a causal relationship between tracheotomy and aspiration status in 25 patients who
underwent fiberoptic endoscopic evaluation of swallowing (FEES) and more recently Kang et al.
[2] showed by Videofluoroscopic Swallow Study (VFSS) that the swallowing parameters related
to laryngeal elevation, pharyngeal constriction, and esophageal opening did not changed
significantly between patients with and without tracheostomy. However until now the study
samples and methods employed to analyze the same purpose were heterogenous. At first the
earlier researches were mostly conducted immediately after tracheostomy, while the latest
ones on cases with stabilized tracheal stoma [3]. Furthermore, the possible mechanisms
hypothesized to explain the increased risk of aspiration were the same both for the studies
about the effect of TT occlusion status and the ones about the presence of TT. Dysphagia is a
dysfunction that deeply impacts especially the patient's post-surgery recovery, particularly
dysphagia is the most common short-term and long-term sequela in subjects undergoing head and
neck oncologic surgery. On this regard the tracheostomy and tracheal tube represent an
unquestionably security condition and a security device respectively. At a time when the
hospitalization is getting shorter and the swallowing rehabilitation training is mainly
carried out in the outpatient setting, it is even more important to clarify the real impact
of tracheal tube. Anyhow, to date the often-held assumption that tracheotomy and placement of
an occluded tracheotomy tube, by themselves, increase incidence of aspiration was not
supported by objective data. The objective of this project is to evaluate, by mean of
oropharyngoesophageal scintigraphy (OPES), the impact of an occluded tracheal tube on
swallowing of patients treated for head and neck cancer before hospital discharge, to provide
further knowledges especially useful for the out-patient care management.
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.
