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DysphagiaNCT05738421

Tracheal Tube and Swallowing After Head and Neck Surgery

An observational study of Dysphagia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dysphagia
What is being tested?
fiberoptic endoscopic evaluation of swallowing
How many people
30 participants
Where
1 siteItaly
Study dates
6 Dec 2021to 6 Oct 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

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)

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Maria Raffaella Marchese

    Roma, 00198

    Jacopo Galli, 3338356370, jacopo.galli@policlinicogemelli.it

    Maria Raffaella Marchese, 3391144556, raffaellamarchese@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: THE IMPACT OF TRACHEAL TUBE ON SWALLOWING IN POST-OPERATIVE HEAD AND NECK CANCER PATIENTS: SCINTIGRAPHIC ANALYSIS

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.
Read the detailed 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.

Conditions
Dysphagia
Being tested
fiberoptic endoscopic evaluation of swallowing
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fiberoptic endoscopic evaluation of swallowingDiagnostic test

    Questionnaire, FEES, OPES

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: five years

Secondary outcomes (1)
  1. To evaluate the features of swallowing

    To evaluate the features of swallowing, specifically bolus transit, in patients affected by head and neck cancer who underwent major oncological surgery.

    Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start6 Dec 2021
  3. Primary completion6 Oct 2026 (estimated)
  4. Study completion6 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738421
Sponsor's protocol ID
4459
Status last verified
Oct 2024
First submitted
1 Feb 2023
Last updated
4 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dysphagia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacopo Galli (3338356370, jacopo.galli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To provide objective data on the bolus transit during swallowing in tracheostomized patients with tracheal tube and without tracheal tube (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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