the First Affiliated Hospital of Guangzhou Medical University
Guangdong, Gaungzhou, 510120, China
Location status: Recruiting
NCT Number: NCT07065565
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Guangdong, Gaungzhou, 510120, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
non-intubated tracheal and carinal reconstruction
intubated tracheal and carinal reconstruction
Time frame: postoperative in-hospital stay up to 30 days
The rate of conversion to intubated approach in the operation
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: postoperative in-hospital stay up to 30 days
blood loss in the operation
Time frame: postoperative in-hospital stay up to 30 days
Length of resection in the operation
Time frame: 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).
Time frame: 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.
Time frame: 1 year after surgery
DFS at 1 year after surgery
Time frame: 1 year after surgery
OS after surgery
Contact information is provided by the study sponsor or research team.
Shuben Li
Other
Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction
Acronym: NOVA-01
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