Upper Aerodigestive Tract NeoplasmsTRACHNCT06857396
Tracheal Exposure Without Tracheostomy Completion in Trans-oral Robotic Oncologic Surgery
An observational study of Upper Aerodigestive Tract Neoplasms, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Upper aerodigestive tract neoplasms surgery results in important trauma, including swelling (oedemas) that can lead to respiratory tract obstruction and death from suffocation. To prevent this, protective tracheostomy is performed, allowing patients to breathe through a cannula during the critical phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Aerodigestive Tract Neoplasms
- What is being tested?
- PREPA-TRACH
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2025to 7 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients managed for an upper airway and digestive tract carcinoma with a trans-oral robotic surgery with tracheal exposure performed during the surgical procedure without immediate tracheotomy completion.
Who may be able to join
- Adult patients (≥ 18 years)
- All patients managed for an upper airway and digestive tract carcinoma with trans-oral robotic surgery, with tracheal exposure performed during the surgical procedure without immediate tracheostomy completion.
Who cannot join
- Patients with immediate complete laryngectomy or complete pharyngolaryngectomy
- Patient opposition
- Patient under legal guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
ENT and oncologic surgery department, Sainte-Musse Hospital
Toulon, Var, 83056
About this study
Official title: Tracheal Exposure Without Tracheostomy Completion : a New Protocol for Airway Management in Trans-oral Robotic Oncologic Surgery
Upper aerodigestive tract neoplasms surgery results in important trauma, including swelling (oedemas) that can lead to respiratory tract obstruction and death from suffocation. To prevent this, protective tracheostomy is performed, allowing patients to breathe through a cannula during the critical phase. Although tracheostomy is reassuring, it presents complications, including swallowing disorders, refeeding delay and pulmonary infections. It generates anxiety for patients and can prevent them from communicating, which can affect their psychological well-being during hospitalization.
In Sainte Musse Hospital, patients who undergo upper aerodigestive tract neoplasms surgery are continuously monitored in intensive care unit. For some "at risk" patients, tracheostomy preparation is performed during operation with tracheal exposure but no incision. If dyspnea occurs, reanimators can quickly access to trachea and proceed to tracheostomy completion. This method, called PREPA-TRACH, avoids unnecessary tracheostomies while minimizing risks for the patients who would need it. Study purpose is to assess the security and reliability of this PREPA-TRACH protocol.
Read the detailed description
This retrospective descriptive monocentric study aims at producing a descriptive series of patients who underwent tracheal exposure in case of tracheostomy hoping to avoid them a complete tracheostomy. Its purpose is to demonstrate on one hand the reliability and security of this technique and on the other hand to define some imperative criteria of surgical indication for tracheostomy or no tracheostomy. The number of patients included corresponds to the eligible patients cohort of Hôpital Sainte Musse ENT surgery department over the 10 last years.
- Conditions
- Upper Aerodigestive Tract Neoplasms
- Being tested
- PREPA-TRACH
- Keywords
- Tracheostomy, Upper aerodigestive tract neoplasms, Robotic-assisted surgery, Unnecessary surgery, Surgery complications
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREPA-TRACHProcedure or surgery
Tracheal exposure without tracheostomy completion during trans-oral robotic oncologic surgery
| Study group | Role | What they receive |
|---|---|---|
| PREPA-TRACH Patient cohort | Patients included in the PREPA TRACH surgery protocol Receives: Procedure: PREPA-TRACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheostomy completion rate
The number of post-operatory complete tracheostomies finally performed over the total number of patients included in the PREPA-TRACH protocol will be calculated.
Measured: Up to 3 hours
Secondary outcomes (2)
Overall survival rate
Number of patients included in the PREPA-TRACH protocol who died because of post-operatory asphyxia.
Measured: Up to 3 hours
Hospital length of stay
Average hospital length of stay will be calculated depending on whether tracheostomy was finally performed or not.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start7 Mar 2025
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Aerodigestive Tract NeoplasmsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume ROUGIER, MD, Study director, CHITS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857396
- Sponsor's protocol ID
- 2025-CHITS-004
- Acronym
- TRACH
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poissonnet V, Chabrillac E, Schultz P, Moriniere S, Gorphe P, Baujat B, Garrel R, Lasne-Cardon A, Villeneuve A, Chambon G, Fakhry N, Aubry K, Dufour X, Malard O, Mastronicola R, Vairel B, Gallet P, Ceruse P, Jegoux F, Ton Van J, De Bonnecaze G, Vergez S. Airway management during transoral robotic surgery for head and neck cancers: a French GETTEC group survey. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3619-3627. doi: 10.1007/s00405-021-07188-4. Epub 2022 Jan 23.
PubMed 35066651Mandal R, Duvvuri U, Ferris RL, Kaffenberger TM, Choby GW, Kim S. Analysis of post-transoral robotic-assisted surgery hemorrhage: Frequency, outcomes, and prevention. Head Neck. 2016 Apr;38 Suppl 1:E776-82. doi: 10.1002/hed.24101. Epub 2015 Jul 15.
PubMed 25916790
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Exposure Without Tracheostomy Completion : a New Protocol for Airway Management in Trans-oral Robotic Oncologic Surgery
- ClinicalTrials.gov ID
- NCT06857396
- Acronym / sponsor ID
- TRACH / 2025-CHITS-004
- Conditions
- Upper Aerodigestive Tract Neoplasms
- Keywords
- Tracheostomy, Upper aerodigestive tract neoplasms, Robotic-assisted surgery, Unnecessary surgery, Surgery complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 4 Mar 2025 (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.
Upper aerodigestive tract neoplasms surgery results in important trauma, including swelling (oedemas) that can lead to respiratory tract obstruction and death from suffocation. To prevent this, protective tracheostomy is performed, allowing patients to breathe through a cannula during the critical phase. Although tracheostomy is reassuring, it presents complications, including swallowing disorders, refeeding delay and pulmonary infections. It generates anxiety for patients and can prevent them from communicating, which can affect their psychological well-being during hospitalization.
In Sainte Musse Hospital, patients who undergo upper aerodigestive tract neoplasms surgery are continuously monitored in intensive care unit. For some "at risk" patients, tracheostomy preparation is performed during operation with tracheal exposure but no incision. If dyspnea occurs, reanimators can quickly access to trachea and proceed to tracheostomy completion. This method, called PREPA-TRACH, avoids unnecessary tracheostomies while minimizing risks for the patients who would need it. Study purpose is to assess the security and reliability of this PREPA-TRACH protocol.
Detailed description
This retrospective descriptive monocentric study aims at producing a descriptive series of patients who underwent tracheal exposure in case of tracheostomy hoping to avoid them a complete tracheostomy. Its purpose is to demonstrate on one hand the reliability and security of this technique and on the other hand to define some imperative criteria of surgical indication for tracheostomy or no tracheostomy. The number of patients included corresponds to the eligible patients cohort of Hôpital Sainte Musse ENT surgery department over the 10 last years.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREPA-TRACH Patient cohort | – | Procedure: PREPA-TRACHPatients included in the PREPA TRACH surgery protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients managed for an upper airway and digestive tract carcinoma with a trans-oral robotic surgery with tracheal exposure performed during the surgical procedure without immediate tracheotomy completion.
Key inclusion criteria (2 listed)
- Adult patients (≥ 18 years)
- All patients managed for an upper airway and digestive tract carcinoma with trans-oral robotic surgery, with tracheal exposure performed during the surgical procedure without immediate tracheostomy completion.
Key exclusion criteria (3 listed)
- Patients with immediate complete laryngectomy or complete pharyngolaryngectomy
- Patient opposition
- Patient under legal guardianship
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 |
|---|---|---|
| PREPA-TRACHTracheal exposure without tracheostomy completion during trans-oral robotic oncologic surgery | Procedure or surgery | PREPA-TRACH Patient cohort |
Primary outcome
Tracheostomy completion rate
Time frame: Up to 3 hours
The number of post-operatory complete tracheostomies finally performed over the total number of patients included in the PREPA-TRACH protocol will be calculated.
2 secondary outcomes
Overall survival rate
Time frame: Up to 3 hours
Hospital length of stay
Time frame: Up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 35066651Poissonnet V, Chabrillac E, Schultz P, Moriniere S, Gorphe P, Baujat B, Garrel R, Lasne-Cardon A, Villeneuve A, Chambon G, Fakhry N, Aubry K, Dufour X, Malard O, Mastronicola R, Vairel B, Gallet P, Ceruse P, Jegoux F, Ton Van J, De Bonnecaze G, Vergez S. Airway management during transoral robotic surgery for head and neck cancers: a French GETTEC group survey. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3619-3627. doi: 10.1007/s00405-021-07188-4. Epub 2022 Jan 23.
- Background: PubMed 25916790Mandal R, Duvvuri U, Ferris RL, Kaffenberger TM, Choby GW, Kim S. Analysis of post-transoral robotic-assisted surgery hemorrhage: Frequency, outcomes, and prevention. Head Neck. 2016 Apr;38 Suppl 1:E776-82. doi: 10.1002/hed.24101. Epub 2015 Jul 15.
- 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.
Guillaume ROUGIER, MD study director
CHITS
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 Upper Aerodigestive Tract Neoplasms, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Feb 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheostomy completion rate (time frame: Up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857396, which also lists 2 linked publications.
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 12 Feb 2026.