Mediastinal Neoplasm, Non-intubated Anesthesia, Tubeless, VATS
Conditions
Keywords
Non-intubated Anesthesia, Tubeless, Mediastinal Neoplasm, VATS
Brief summary
In recent year, non-intubated anesthesia had emerged as an available and promising alternative for thoracic procedure. However, its safety and feasibility in video-assisted thoracoscopic surgery (VATS) for mediastinal neoplasm remain controversial. This randomized controlled trial is designed to evaluate the impact of the non-intubated approach on surgical and perioperative outcomes in patients undergoing mediastinal neoplasm resection.
Detailed description
Non-intubated anesthesia has gained widespread adoption in recent years, representing a significant advancement in both thoracic surgery and anesthetic practice. The surgical safety and feasibility of tubeless VATS for mediastinal neoplasm has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. Accordingly, this randomized controlled trial aims to evaluate whether the non-intubated approach provides comparable short-term and long-term outcomes to the conventional intubated technique in VATS for mediastinal neoplasm resection.
Interventions
PROCEDURENon-intubated VATS for mediastinal neoplasm
Non-intubated VATS for mediastinal neoplasm
PROCEDUREIntubated VATS for mediastinal neoplasm
Intubated VATS for mediastinal neoplasm
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
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. Mediastinal neoplasm was diagnosed by chest enhanced CT 2. The patients with age ≥ 18 and ≤ 80 years old 3. The patients whose tumor diameter was \<6 cm 4. ASA grade: I-III 5. The patients should understand the research and sign the informed consent
Exclusion criteria
1. Imaging examinations revealed that the tumor had invaded adjacent organs, with evidence of pleural or pericardial dissemination, as well as lymphatic and/or hematogenous metastases 2. Patients with a confirmed history of congestive heart failure, poorly controlled angina despite medical therapy, electrocardiogram-confirmed myocardial infarction with transmural involvement, uncontrolled hypertension, clinically significant valvular heart disease, or high-risk arrhythmias not adequately managed 3. Patients with concurrent active malignancies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate to open surgery | postoperative in-hospital stay up to 30 days | Proportion of patients requiring conversion from VATS to open surgery. |
| Conversion rate to intubated anesthesia | postoperative in-hospital stay up to 30 days | Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia |
| Postoperative complication rate | postoperative in-hospital stay up to 30 days | Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | postoperative in-hospital stay up to 30 days | ICU stay (in days), defined as the duration from ICU admission post-surgery to ICU discharge. |
| Hospital stay | postoperative in-hospital stay up to 30 days | Hospital stay, defined as the duration from the day of surgery to the day of discharge. |
| Volume of postoperative drainage | postoperative in-hospital stay up to 30 days | Volume of postoperative drainage, measured from the end of surgery until drain removal. |
| R0 rate | postoperative in-hospital stay up to 30 days | R0 resection rate |
| 1-year overall survival(OS) | 1 year after surgery | 1-year overall survival(OS), defined as the percentage of patients alive at 12 months from the date of surgery or treatment initiation, irrespective of disease recurrence or progression. |
| Quality of life (QOL) at 3 month | Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being. | 3 months after discharge |
| 1-year disease-free survival (DFS) | 1 year after surgery | 1-year disease-free survival (DFS), defined as the percentage of patients alive without evidence of tumor recurrence or progression at 12 months. |
| Operation 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). |
| Intraoperative bleeding loss | postoperative in-hospital stay up to 30 days | The volume of bleeding during the surgery. |
Countries
China
Contacts
Primary ContactShuben Li, Deputy Director
Outcome results
None listed