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Tracheal Exposure Without Tracheostomy Completion in Trans-oral Robotic Oncologic Surgery

NCT06857396 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • Upper Aerodigestive Tract Neoplasms

Interventions

PROCEDURE

PREPA-TRACH

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

Sponsors & Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • Guillaume ROUGIER, MD · CHITS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2025-07-07
Completion
2025-07-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857396 on ClinicalTrials.gov