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Completed

NCT Number: NCT07097584

Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Intubation allocation time

    Time frame: During induction of general anesthesia

    The time duration required to complete Double-lumen tube intubation and positioning

Secondary outcomes

  1. Time of laryngoscope insertion

    Time frame: During induction of general anesthesia

  2. Time of double-lumen tube insertion

    Time frame: 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.

  3. Time of successfully positioning of fiberoptic bronchoscope in supine position

    Time frame: 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).

  4. First-pass success rate of intubation

    Time frame: 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

  5. Number of intubation attempts

    Time frame: During induction of general anesthesia

  6. The incidence of Intubation difficulty

    Time frame: 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)

  7. The incidence of air leakage in double-lumen bronchial tubes

    Time frame: 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.

  8. Videolaryngoscope VIDIAC score

    Time frame: 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.

  9. Intubation resistance

    Time frame: During induction of general anesthesia

    Intubation Resistance

    • No resistance
    • Mild resistance
    • Moderate resistance (Significant resistance encountered at the subglottis, although the tracheal tube segment can be advanced past the subglottis)
    • Severe resistance(The tracheal tube segment cannot pass the subglottis and must be replaced with the next smaller size)
  10. Intubation depth

    Time frame: During induction of general anesthesia

    LDLT depth (cm) = 12 + [patient height (cm) × 10-¹

  11. Adverse events during intubation

    Time frame: During induction of general anesthesia

  12. Misplacement rate after position change (movement distance>1.0 cm)

    Time frame: During induction of general anesthesia

    if the DLT moves more than 1.0cm after the first intubation, it is regarded as Misplacement

  13. Campos atelectasis classification

    Time frame: 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.

  14. Accumulated usage times of fiberoptic bronchoscope

    Time frame: 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

  15. The incidence of misplacement during the operation

    Time frame: during the operation

    if the DLT moves more than 1.0cm after the first intubation, it is regarded as Misplacement

  16. Number of intraoperative double-lumen tube adjustments

    Time frame: During the operation

  17. The incidence of hypoxemia intraoperatively

    Time frame: During the operation

    hypoxemia means arterial oxygen saturation≤90%, and ≥60s

  18. Intraoperative single-lung ventilation time

    Time frame: through study completion,an average of 1-4 hours

  19. Carina mucosa injury score

    Time frame: 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

  20. Multiplanar Reconstruction(MPR) of lung CT measurement data

    Time frame: 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

  21. Bronchial window measurement data

    Time frame: 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

  22. PACU stay time

    Time frame: after operation,an average of 60-120 minutes

  23. The incidence of sore throat

    Time frame: One hour, twenty-four hours, forty-eight hours after surgery

  24. The incidence of postoperative cough

    Time frame: One hour, twenty-four hours, forty-eight hours ,thirty days after surgery

  25. Postoperative pain score

    Time frame: 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."

  26. Postoperative chest tube removal time

    Time frame: after operation through study completion,an average of 3-4 days

  27. Length of hospital stay after surgery

    Time frame: after operation through study completion,an average of 3-7 days

  28. Postoperative 30-day complications

    Time frame: within 30 days after surgery

    Postoperative 30-day complications by using Clavien-Dindo score

  29. The incidence of postoperative pulmonary complications

    Time frame: 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.

  30. the postoperative recovery

    Time frame: 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

  31. heart rate before and after intubation

    Time frame: Baseline. At 1,2,5 minutes after intubation.

  32. mean arterial pressure before and after intubation

    Time frame: baseline.At 1,2,5 minutes after intubation.

  33. Intraoperative Partial Pressure of Arterial Oxygen (PaO₂)

    Time frame: During the operation

    arterial blood can be drawn from the specimen for examination.

  34. Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂)

    Time frame: During the operation

    arterial blood can be drawn from the specimen for examination.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women: a Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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