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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Down-size Left Double-lumen Endobronchial Tube Group | Experimental |
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| The Regular Left Double-lumen Endobronchial Tube Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation allocation time | The time duration required to complete Double-lumen tube intubation and positioning | During induction of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Time of laryngoscope insertion | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang cancer hospital | Hangzhou | Zhejiang | 310022 | China |
We will share data on ClinicalTrials.gov, and data sharing will be always available.
starting about 6 months after publication
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The anesthesiologists do not implement the blinding method for the patient grouping, while the physicians conducting the postoperative follow-up implement the blinding method for the grouping.
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| Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods | Device | 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. |
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| 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). | 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 | During induction of general anesthesia |
| Number of intubation attempts | 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) | 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. | 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. | During induction of general anesthesia |
| Intubation resistance | Intubation Resistance
| During induction of general anesthesia |
| Intubation depth | LDLT depth (cm) = 12 + [patient height (cm) × 10-¹](streamdown:incomplete-link) | During induction of general anesthesia |
| Adverse events during intubation | 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 | 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. | 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 | 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 | during the operation |
| Number of intraoperative double-lumen tube adjustments | During the operation |
| The incidence of hypoxemia intraoperatively | hypoxemia means arterial oxygen saturation≤90%, and ≥60s | During the operation |
| Intraoperative single-lung ventilation time | 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 | 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 | 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 | after operation,an average of 1-3 days |
| PACU stay time | after operation,an average of 60-120 minutes |
| The incidence of sore throat | One hour, twenty-four hours, forty-eight hours after surgery |
| The incidence of postoperative cough | 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." | twenty-four hours, forty-eight hours ,thirty days after surgery |
| Postoperative chest tube removal time | after operation through study completion,an average of 3-4 days |
| Length of hospital stay after surgery | after operation through study completion,an average of 3-7 days |
| Postoperative 30-day complications | Postoperative 30-day complications by using Clavien-Dindo score | 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. | 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 | on postoperative day 1 |
| heart rate before and after intubation | Baseline. At 1,2,5 minutes after intubation. |
| mean arterial pressure before and after intubation | 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. | During the operation |
| Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂) | arterial blood can be drawn from the specimen for examination. | During the operation |