Clinical trial · Observational
Tracheal Exposure Without Tracheostomy Completion in Trans-oral Robotic Oncologic Surgery
Tracheal Exposure Without Tracheostomy Completion : a New Protocol for Airway Management in Trans-oral Robotic Oncologic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Aerodigestive Tract Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PREPA-TRACH | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PREPA-TRACH Patient cohort
- description
- Patients included in the PREPA TRACH surgery protocol
- interventionNames
- Procedure: PREPA-TRACH
Primary outcomes (1)
- measure
- Tracheostomy completion rate
- timeFrame
- Up to 3 hours
- description
- The number of post-operatory complete tracheostomies finally performed over the total number of patients included in the PREPA-TRACH protocol will be calculated.
Secondary outcomes (2)
- measure
- Overall survival rate
- timeFrame
- Up to 3 hours
- description
- Number of patients included in the PREPA-TRACH protocol who died because of post-operatory asphyxia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with immediate complete laryngectomy or complete pharyngolaryngectomy * Patient opposition * Patient under legal guardianship
References
Publications (2)
- BACKGROUNDPoissonnet 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. PMID 35066651
- BACKGROUNDMandal 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. PMID 25916790