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In recent year, non-intubated anesthesia had emerged as an available alternative for thoracic procedure. Whether non-intubated tracheal/carinal reconstruction confers distinct perioperative advantages over the conventional intubated approach remains uncertain. The purpose of this study was to evaluate the safety and perioperative outcomes of non-intubated versus intubated approaches in tracheal and carinal reconstruction.
Tracheal/carinal resection and reconstruction remains a technically demanding procedure with high risks of morbidity and mortality. Traditionally, tracheal surgery is performed under intubated anesthesia, with intermittent endotracheal ventilation to maintain oxygenation during airway reconstruction. However, endotracheal intubation with cross-field ventilation obstructs the surgical field and potentially complicating the reconstruction procedure. Non-intubated anesthesia have has gained widespread adoption for modern thoracic surgery. However, the safety and feasibility of non-intubated tracheal and carinal reconstruction have not been studied by randomized controlled trial. So, this randomized controlled trial aims to evaluate whether the non-intubated approach offers comparable short-term and long-term outcomes to the conventional intubated procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-intubated group | Experimental | Surgical procedure: non-intubated tracheal and carinal reconstruction |
|
| Intubated group | Active Comparator | Surgical procedure: intubated tracheal and carinal reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-intubated tracheal and carinal reconstruction | Procedure | non-intubated tracheal and carinal reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | The rate of conversion to intubated approach in the operation | postoperative in-hospital stay up to 30 days |
| Postoperative complications rate | Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0. | postoperative in-hospital stay up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin). | postoperative in-hospital stay up to 30 days |
| Length of stay (LOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuben Li | Contact | 86+(020) 8306 2114 | 13500030280@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangdong | Gaungzhou | 510120 | China |
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| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| intubated tracheal and carinal reconstruction | Procedure | intubated tracheal and carinal reconstruction |
|
Length of stay is the duration for enrolled patients until the date of meeting the criteria of hospital discharge since the date of surgery.
| postoperative in-hospital stay up to 30 days |
| Postoperative ICU stay | Postoperative hospital stay is the duration for each patients until the date of meeting the criteria of ICU discharge since the date of surgery. | postoperative in-hospital stay up to 30 days |
| Intraoperative bleeding loss | blood loss in the operation | postoperative in-hospital stay up to 30 days |
| Length of resection | Length of resection in the operation | postoperative in-hospital stay up to 30 days |
| Reconstruction time | Reconstruction time was defined as the time between the start of resection (tracheal) and the finish of reconstruction (tracheal). | postoperative in-hospital stay up to 30 days |
| Volume of postoperative drainage | The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery. | postoperative in-hospital stay up to 30 days |
| 1-year disease-free survival (DFS) | DFS at 1 year after surgery | 1 year after surgery |
| 1-year overall survival(OS) | OS after surgery | 1 year after surgery |