Tubeless Tracheal and Carinal Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShuben Li
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Airway diseases were diagnosed by chest enhanced CT and bronchoscopy
The patients with age ≥ 18 and ≤ 80 years old
ASA (American Society of Anesthesiologists) stage: I-III
sign the informed consent. -
Disqualifiers
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
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
Airway anatomical abnormalities due to a history of surgery
Patients present with other malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
non-intubated tracheal and carinal reconstruction
Procedure/Surgerynon-intubated tracheal and carinal reconstruction
intubated tracheal and carinal reconstruction
Procedure/Surgeryintubated tracheal and carinal reconstruction
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Non-intubated groupExperimental treatment 1 intervention
Group B: Intubated groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Conversion rate
The rate of conversion to intubated approach in the operation
Time frame
postoperative in-hospital stay up to 30 days2
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.
Time frame
postoperative in-hospital stay up to 30 daysSecondary outcomes
1
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).
Time frame
postoperative in-hospital stay up to 30 days2
Length of stay (LOS)
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 days3
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.
Time frame
postoperative in-hospital stay up to 30 days4
Intraoperative bleeding loss
blood loss in the operation
Time frame
postoperative in-hospital stay up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shuben Li
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Source ClinicalTrials.gov