Airway Disease, Tracheal Disease
Conditions
Keywords
non-intubated anesthesia, airway disease, tracheal reconstruction, carinal reconstruction
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREnon-intubated tracheal and carinal reconstruction
non-intubated tracheal and carinal reconstruction
PROCEDUREintubated tracheal and carinal reconstruction
intubated tracheal and carinal reconstruction
Sponsors
Shuben Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Airway diseases were diagnosed by chest enhanced CT and bronchoscopy 2. The patients with age ≥ 18 and ≤ 80 years old 3. ASA (American Society of Anesthesiologists) stage: I-III 4. sign the informed consent. -
Exclusion criteria
1. The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control 2. The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy 3. Airway anatomical abnormalities due to a history of surgery 4. Patients present with other malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | postoperative in-hospital stay up to 30 days | The rate of conversion to intubated approach in the operation |
| Postoperative complications rate | postoperative in-hospital stay up to 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative ICU stay | postoperative in-hospital stay up to 30 days | Postoperative hospital stay is the duration for each patients until the date of meeting the criteria of ICU discharge since the date of surgery. |
| Intraoperative bleeding loss | postoperative in-hospital stay up to 30 days | blood loss in the operation |
| Length of resection | postoperative in-hospital stay up to 30 days | Length of resection in the operation |
| Operative time | postoperative in-hospital stay up to 30 days | Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin). |
| Volume of postoperative drainage | postoperative in-hospital stay up to 30 days | The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery. |
| 1-year disease-free survival (DFS) | 1 year after surgery | DFS at 1 year after surgery |
| 1-year overall survival(OS) | 1 year after surgery | OS after surgery |
| Reconstruction time | postoperative in-hospital stay up to 30 days | Reconstruction time was defined as the time between the start of resection (tracheal) and the finish of reconstruction (tracheal). |
| Length of stay (LOS) | postoperative in-hospital stay up to 30 days | Length of stay is the duration for enrolled patients until the date of meeting the criteria of hospital discharge since the date of surgery. |
Countries
China
Contacts
Primary ContactShuben Li
Outcome results
None listed