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.
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
- Recruiting
Maria Raffaella Marchese
Roma, 00198
Jacopo Galli, 3338356370, jacopo.galli@policlinicogemelli.it
Maria Raffaella Marchese, 3391144556, raffaellamarchese@gmail.com
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.
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)
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.
- First posted22 Feb 2023
- Study start6 Dec 2021
- Primary completion6 Oct 2026 (estimated)
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galli Jacopo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Jacopo Galli, Principal investigator, Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMPACT OF TRACHEAL TUBE ON SWALLOWING IN POST-OPERATIVE HEAD AND NECK CANCER PATIENTS: SCINTIGRAPHIC ANALYSIS
- ClinicalTrials.gov ID
- NCT05738421
- Acronym / sponsor ID
- 4459
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Oct 2026 (estimated)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- 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)
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fiberoptic endoscopic evaluation of swallowingQuestionnaire, FEES, OPES | Diagnostic test | – |
Primary outcome
To provide objective data on the bolus transit during swallowing in tracheostomized patients with tracheal tube and without tracheal tube
Time frame: five years
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.
1 secondary outcome
To evaluate the features of swallowing
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacopo Galli principal investigator
Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma
1 site in 1 country: see every site and its status.
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.