Asian, Thoracic Surgery With One-lung Ventilation, Women
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESelecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method
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.
DEVICESelecting the size of a Left Double-lumen endobronchialtube according to traditional methods
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.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for thoracoscopic pulmonary resection using a left double-lumen tube under general anesthesia. * Patients aged 18-80 years * Chest CT scan in our hospital within one month before surgery * American Society of Anesthesiologists (ASA) physical status I to III
Exclusion criteria
* Anticipated difficult airway * Patients with tracheal/left main bronchus anomalies * Height \<152 cm * Refused to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation allocation time | During induction of general anesthesia | The time duration required to complete Double-lumen tube intubation and positioning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of laryngoscope insertion | During induction of general anesthesia | — |
| Time of double-lumen tube insertion | During induction of general anesthesia | 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 of successfully positioning of fiberoptic bronchoscope in supine position | During induction of general anesthesia | 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). |
| First-pass success rate of intubation | During induction of general anesthesia | Fiberoptic bronchoscopic adjustment immediately following intubation，if the DLT moves less than 1.0cm after the first intubation, it is regarded as successful |
| Number of intubation attempts | During induction of general anesthesia | — |
| The incidence of Intubation difficulty | During induction of general anesthesia | Intubation difficulty（when an anesthetist with over 3 years of DLT intubation experience needs ≥3 attempts or intubation time ≥10 min during DLT intubation） |
| The incidence of air leakage in double-lumen bronchial tubes | During induction of general anesthesia | 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. |
| Videolaryngoscope VIDIAC score | During induction of general anesthesia | 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. |
| Intubation resistance | During induction of general anesthesia | 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) |
| Intubation depth | During induction of general anesthesia | LDLT depth (cm) = 12 + \[patient height (cm) × 10-¹ |
| Adverse events during intubation | During induction of general anesthesia | — |
| Misplacement rate after position change (movement distance>1.0 cm) | During induction of general anesthesia | if the DLT moves more than 1.0cm after the first intubation, it is regarded as Misplacement |
| Campos atelectasis classification | 5 minutes and 20 minutes after the distal port of the double-lumen tube is opened | 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. |
| Accumulated usage times of fiberoptic bronchoscope | During the operation | 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 |
| The incidence of misplacement during the operation | during the operation | if the DLT moves more than 1.0cm after the first intubation, it is regarded as Misplacement |
| Number of intraoperative double-lumen tube adjustments | During the operation | — |
| The incidence of hypoxemia intraoperatively | During the operation | hypoxemia means arterial oxygen saturation≤90%, and ≥60s |
| Intraoperative single-lung ventilation time | through study completion，an average of 1-4 hours | — |
| Carina mucosa injury score | During the operation | 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 |
| Multiplanar Reconstruction（MPR) of lung CT measurement data | after operation，an average of 1-3 days | 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 |
| Bronchial window measurement data | after operation，an average of 1-3 days | Bronchial window measurement data Left main bronchus anteroposterior diameter (APD-LMB) (mm) DLT model selected based on bronchial window |
| 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 | twenty-four hours, forty-eight hours ，thirty days after surgery | 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." |
| 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 | within 30 days after surgery | Postoperative 30-day complications by using Clavien-Dindo score |
| The incidence of postoperative pulmonary complications | within 30 days after surgery | 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. |
| the postoperative recovery | on postoperative day 1 | 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 |
| 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) | During the operation | arterial blood can be drawn from the specimen for examination. |
| Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂) | During the operation | arterial blood can be drawn from the specimen for examination. |
Countries
China
Outcome results
None listed