Pulmonary Nodules
Conditions
Keywords
Thoracic Surgery, Anesthetic Management, Double-Lumen Tube Intubation, Chest CT, 3D Airway Reconstruction
Brief summary
This is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby reducing the rate of intubation failure and the occurrence of perioperative adverse events to a certain extent.
Interventions
PROCEDURE3D Airway Reconstruction-Guided Double-Lumen Tube Intubation
Patients in this group will undergo preoperative chest CT scanning. The DICOM data will be imported into reconstruction software to create a 3D model of the trachea and bronchi. The diameter of the trachea, left and right main bronchus will be measured on the 3D model to select the appropriate size of the double-lumen tube (DLT). The 3D model can also provide suggestions on the depth of intubation and the bifurcation angle of the bronchus. During anesthesia induction, the selected DLT will be inserted based on the measurements derived from the 3D model.
PROCEDUREGender and Height-Based Double-Lumen Tube Selection
Patients in this group will undergo DLT intubation guided by conventional clinical experience. The DLT size will be selected based on the patient's gender and height according to standard clinical formulas or empirical rules. No preoperative 3D airway reconstruction will be performed for tube sizing.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ①Aged 18-75 years, undergoing elective VATS thoracic surgery, with DLT during the procedure; ②ASA physical status I-III; ③ Preoperative chest CT data available for 3D reconstruction; ④ Agree to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
* ① Preoperative presence of severe respiratory diseases, such as severe chronic obstructive pulmonary disease (COPD), pulmonary infection, and asthma exacerbation; ② Clinically assessed as a difficult airway, such as limited head tilt, spinal deformity, airway or head and neck masses, significant abnormalities in airway anatomy, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of first intubation without the use of fiberoptic bronchoscope | Perioperative | The success rate of first intubation without using a fiberoptic bronchoscope is defined as follows: if no adjustment or only minor adjustment of less than 5mm is required after fiberoptic bronchoscopy, and any of the following criteria is met, it is considered unsuccessful: ① difficult insertion, requiring a change in the size of the double-lumen tube or other methods of pulmonary isolation; ② insertion into the opposite main bronchus; ③ bronchial cuff protruding into the carina (more than 50% of the cuff); ④ the edge of the bronchial cuff cuff is not visible at the entrance of the bronchus; ⑤ covering more than 50% of the opening of the right upper lung; ⑥ fiberoptic bronchoscopy cannot distinguish between tracheal/bronchial anatomical structures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation duration | Perioperative | — |
| The incidence of switching to a different DLT size or adopting alternative intubation techniques | Perioperative | — |
| Intraoperative airway pressure | Perioperative | Airway peak pressure, plateau pressure, and compliance during supine dual lung ventilation and lateral single lung ventilation |
| Surgeon satisfaction with lung collapse | Perioperative | The surgeon satisfaction scale for lung collapse is a commonly used evaluation tool in clinical trials. The scale consists of 11 numbers from 0 to 10, representing varying degrees of satisfaction among surgeons regarding the effect of lung collapse. 0 indicates "very dissatisfied", and the satisfaction level increases progressively, with 10 indicating "very satisfied". |
| Incidence of sore throat | Perioperative and day 1 | — |
| Incidence of hoarseness | Perioperative and day 1 | — |
| Incidence of hypoxemia | Perioperative | — |
| DLT adjustment rate under fiberoptic bronchoscopy in lateral position | Perioperative | — |
Countries
China
Outcome results
None listed