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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06857396
Acronym
TRACH
Enrollment
81
Registered
2025-03-04
Start date
2025-03-07
Completion date
2025-07-07
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Aerodigestive Tract Neoplasms

Keywords

Tracheostomy, Upper aerodigestive tract neoplasms, Robotic-assisted surgery, Unnecessary surgery, Surgery complications

Brief 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. 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.

Interventions

PROCEDUREPREPA-TRACH

Tracheal exposure without tracheostomy completion during trans-oral robotic oncologic surgery

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tracheostomy completion rateUp to 3 hoursThe number of post-operatory complete tracheostomies finally performed over the total number of patients included in the PREPA-TRACH protocol will be calculated.

Secondary

MeasureTime frameDescription
Overall survival rateUp to 3 hoursNumber of patients included in the PREPA-TRACH protocol who died because of post-operatory asphyxia.
Hospital length of stayUp to 3 weeksAverage hospital length of stay will be calculated depending on whether tracheostomy was finally performed or not.

Countries

France

Contacts

STUDY_DIRECTORGuillaume ROUGIER, MD

CHITS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026