The purpose of this experiment is to verify whether selecting a double-lumen tube one size smaller based on the traditional personalized method can shorten the intubation time without increasing ventilation complications when performing tracheal intubation for thoracic surgery in Asian women.Patients receive double-lumen tubes of a size selected based on the traditional personalized method or one size smaller than that chosen by the traditional method during tracheal intubation. The primary outcome is the time duration required to complete Double-lumen tube intubation and positioning.
The selection of double-lumen tube sizes using traditional methods relies on two factors: height and gender. In this study, all patients planned to be enrolled are female, so the traditional corresponding relationship is roughly as follows: For patients with a height of less than 152 cm, a 32Fr (French) tube is often selected. For patients with a height between 152 - 165 cm, a 35Fr tube is often selected. For patients with a height between 165 - 177 cm, a 37Fr tube is often selected. For patients with a height of more than 177 cm, a 39Fr tube is often selected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
180
During tracheal intubation，choose a Left Double-lumen Endobronchial Tubethat is one size smaller than the traditional method.In this study, all patients planned to be enrolled are female. In experimental group the relationship between height and size is roughly as follows: For patients with a height between 152 - 165 cm, a 32Fr (French) tube is often selected. For patients with a height between 165 - 177 cm, a 35Fr tube is often selected. For patients with a height of more than 177 cm, a 37Fr tube is often selected.
During tracheal intubation，choose the regular Left Double-lumen endobronchial tube according to the traditional method. The selection of double-lumen tube sizes using traditional methods relies on two factors: height and gender. In this study, all patients planned to be enrolled are female, so the traditional corresponding relationship is roughly as follows: For patients with a height of less than 152 cm, a 32Fr (French) tube is often selected. For patients with a height between 152 - 165 cm, a 35Fr tube is often selected. For patients with a height between 165 - 177 cm, a 37Fr tube is often selected. For patients with a height of more than 177 cm, a 39Fr tube is often selected.
Zhejiang cancer hospital
Hangzhou, Zhejiang, China
RECRUITINGIntubation allocation time
The time duration required to complete Double-lumen tube intubation and positioning
Time frame: During induction of general anesthesia
Time of laryngoscope insertion
Time frame: During induction of general anesthesia
Time of double-lumen tube insertion
Under videolaryngoscopy，the LDLT (left double-lumen tube) with the stylet is introduced into the glottis with the tip oriented anteriorly. After the bronchial cuff passes through the glottis the stylet is removed and the tube is rotated 90 degrees counterclockwise.The LDLT is then advanced to the predicted depth: LDLT depth (cm) = 12 + \[patient height (cm) × 10-¹\]Intubation time is defined as the period from insertion of the laryngoscope blade to completion of LDLT placement.
Time frame: During induction of general anesthesia
Time of successfully positioning of fiberoptic bronchoscope in supine position
Following intubation, the attending anesthesiologist inserted the fiberoptic bronchoscope (FOB) to reposition the left-sided double-lumen tube (LDLT) for optimal placement.（Confirmed by FOB: The left upper lobe and lower lobe bronchi were clearly visualized through the bronchial lumen, the left mainstem bronchus was seen via the tracheal lumen, and the bronchial cuff was positioned just below the carina).
Time frame: During induction of general anesthesia
First-pass success rate of intubation
Fiberoptic bronchoscopic adjustment immediately following intubation，if the DLT moves less than 1.0cm after the first intubation, it is regarded as successful
Time frame: During induction of general anesthesia
Number of intubation attempts
Time frame: During induction of general anesthesia
The incidence of Intubation difficulty
Intubation difficulty（when an anesthetist with over 3 years of DLT intubation experience needs ≥3 attempts or intubation time ≥10 min during DLT intubation）
Time frame: During induction of general anesthesia
The incidence of air leakage in double-lumen bronchial tubes
After inflating the endotracheal tube cuff with 2-6 ml of air and the bronchial cuff with 1-3 ml of air respectively, cuff pressures are measured and should be \< 25 cm H₂O and \< 20 cm H₂O respectively. Absence of an air leak from the endotracheal tube when peak airway pressure reaches 30 cm H₂O during positive-pressure ventilation is considered an indicator of adequate seal.
Time frame: During induction of general anesthesia
Videolaryngoscope VIDIAC score
The VIDIAC score is comprised of: E, the interaction between the blade tip and epiglottis; V, the best view of the vocal cords from the blade camera; and A, enlargement of the arytenoids. The score range of the VIDIAC score is from -1 to 5 points. The VIDIAC score classification is as follows: Easy, with a score of -1 or 0; Moderate, with a score of 1; Difficult, with a score of 2; Severe, with a score of ≥3.
Time frame: During induction of general anesthesia
Intubation resistance
Intubation Resistance 1. No resistance 2. Mild resistance 3. Moderate resistance (Significant resistance encountered at the subglottis, although the tracheal tube segment can be advanced past the subglottis) 4. Severe resistance(The tracheal tube segment cannot pass the subglottis and must be replaced with the next smaller size)
Time frame: During induction of general anesthesia
Intubation depth
LDLT depth (cm) = 12 + \[patient height (cm) × 10-¹
Time frame: During induction of general anesthesia
Adverse events during intubation
Time frame: During induction of general anesthesia
Misplacement rate after position change (movement distance>1.0 cm)
if the DLT moves more than 1.0cm after the first intubation, it is regarded as Misplacement
Time frame: During induction of general anesthesia
Campos atelectasis classification
Campos Classification of Lung Collapse: Excellent: The operated lung is completely collapsed, the surgical field is satisfactorily exposed, and no intervention by the surgeon is required. Good: The operated lung is mostly collapsed with some residual gas in the lung, but there is no ventilation in the lung, and the surgical field is relatively satisfactorily exposed. Poor: The operated lung is not collapsed or only partially collapsed, which interferes with the surgical operation and requires intervention by the surgeon.
Time frame: 5 minutes and 20 minutes after the distal port of the double-lumen tube is opened
Accumulated usage times of fiberoptic bronchoscope
SaO₂≤90% and ≥1min, airway pressure\>35cm H₂O, poor lung atelectasis, or according to experience, all need to use fiberoptic bronchoscope to confirm the position
Time frame: During the operation
The incidence of misplacement during the operation
if the DLT moves more than 1.0cm after the first intubation, it is regarded as Misplacement
Time frame: during the operation
Number of intraoperative double-lumen tube adjustments
Time frame: During the operation
The incidence of hypoxemia intraoperatively
hypoxemia means arterial oxygen saturation≤90%, and ≥60s
Time frame: During the operation
Intraoperative single-lung ventilation time
Time frame: through study completion，an average of 1-4 hours
Carina mucosa injury score
after repositioning to supine position, the double-lumen tube is withdrawn to the main trachea, and the mucosa within a 1cm radius of the carina is assessed using a fiberoptic bronchoscope
Time frame: During the operation
Multiplanar Reconstruction（MPR) of lung CT measurement data
Left main bronchus transverse diameter (TD-LMB) (cm) Left main bronchus anteroposterior diameter (APD-LMB) (mm) Left main bronchus equivalent diameter (ED-LMB) (cm) DLT model selected based on MPR
Time frame: after operation，an average of 1-3 days
Bronchial window measurement data
Bronchial window measurement data Left main bronchus anteroposterior diameter (APD-LMB) (mm) DLT model selected based on bronchial window
Time frame: after operation，an average of 1-3 days
PACU stay time
Time frame: after operation，an average of 60-120 minutes
The incidence of sore throat
Time frame: One hour, twenty-four hours, forty-eight hours after surgery
The incidence of postoperative cough
Time frame: One hour, twenty-four hours, forty-eight hours ，thirty days after surgery
Postoperative pain score
The Numeric Rating Scale (NRS) is a widely used tool for assessing pain intensity, recognized for its simplicity, ease of administration, and high reliability across various patient populations. The scale ranges from 0 to 10, where: 0 indicates "no pain at all." 10 represents "the worst imaginable pain."
Time frame: twenty-four hours, forty-eight hours ，thirty days after surgery
Postoperative chest tube removal time
Time frame: after operation through study completion，an average of 3-4 days
Length of hospital stay after surgery
Time frame: after operation through study completion，an average of 3-7 days
Postoperative 30-day complications
Postoperative 30-day complications by using Clavien-Dindo score
Time frame: within 30 days after surgery
The incidence of postoperative pulmonary complications
postoperative pulmonary complications include: Pneumonia,Atelectasis,Respiratory failure,Pleural effusion,Bronchospasm,Pulmonary embolism If any of the above conditions is present, it is considered that there is a postoperative pulmonary complication.
Time frame: within 30 days after surgery
the postoperative recovery
The postoperative recovery is assessed using the quality of recovery-15 questionnaire (QoR-15) .The QoR-15 has 15 questions. Each question is rated on a 10-point scale, ranging from 0 (none of the time or poor) to 10 (all of the time or excellent). The maximum score (best recovery) is 150
Time frame: on postoperative day 1
heart rate before and after intubation
Time frame: Baseline. At 1，2,5 minutes after intubation.
mean arterial pressure before and after intubation
Time frame: baseline.At 1，2,5 minutes after intubation.
Intraoperative Partial Pressure of Arterial Oxygen (PaO₂)
arterial blood can be drawn from the specimen for examination.
Time frame: During the operation
Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
arterial blood can be drawn from the specimen for examination.
Time frame: During the operation
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