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WomenNCT07097584

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

A study testing Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method and Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods in people with Women and Asian, run by Zhejiang Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method and Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
28 Jul 2025to 23 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Anticipated difficult airway
  • Patients with tracheal/left main bronchus anomalies
  • Height <152 cm
  • Refused to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zhejiang cancer hospital

    Hangzhou, Zhejiang, 310022

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method, Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional methodDevice

    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 methodsDevice

    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.

Study groups in NCT07097584
Study groupRoleWhat they receive
The Down-size Left Double-lumen Endobronchial Tube GroupExperimentalNot described
Receives: Device: Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method
The Regular Left Double-lumen Endobronchial Tube GroupActive comparatorNot described
Receives: Device: Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intubation allocation time

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

    Measured: During induction of general anesthesia

Secondary outcomes (34)
  1. Time of laryngoscope insertion

    Measured: During induction of general anesthesia

  2. 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.

    Measured: During induction of general anesthesia

  3. 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).

    Measured: During induction of general anesthesia

  4. 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

    Measured: During induction of general anesthesia

  5. Number of intubation attempts

    Measured: During induction of general anesthesia

  6. 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)

    Measured: During induction of general anesthesia

  7. 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.

    Measured: During induction of general anesthesia

  8. 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.

    Measured: During induction of general anesthesia

  9. 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)

    Measured: During induction of general anesthesia

  10. Intubation depth

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

    Measured: During induction of general anesthesia

  11. Adverse events during intubation

    Measured: During induction of general anesthesia

  12. 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

    Measured: During induction of general anesthesia

  13. 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.

    Measured: 5 minutes and 20 minutes after the distal port of the double-lumen tube is opened

  14. 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

    Measured: During the operation

  15. The incidence of misplacement during the operation

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

    Measured: during the operation

  16. Number of intraoperative double-lumen tube adjustments

    Measured: During the operation

  17. The incidence of hypoxemia intraoperatively

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

    Measured: During the operation

  18. Intraoperative single-lung ventilation time

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

  19. 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

    Measured: During the operation

  20. 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

    Measured: after operation,an average of 1-3 days

  21. Bronchial window measurement data

    Bronchial window measurement data Left main bronchus anteroposterior diameter (APD-LMB) (mm) DLT model selected based on bronchial window

    Measured: after operation,an average of 1-3 days

  22. PACU stay time

    Measured: after operation,an average of 60-120 minutes

  23. The incidence of sore throat

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

  24. The incidence of postoperative cough

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

  25. 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."

    Measured: twenty-four hours, forty-eight hours ,thirty days after surgery

  26. Postoperative chest tube removal time

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

  27. Length of hospital stay after surgery

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

  28. Postoperative 30-day complications

    Postoperative 30-day complications by using Clavien-Dindo score

    Measured: within 30 days after surgery

  29. 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.

    Measured: within 30 days after surgery

  30. 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

    Measured: on postoperative day 1

  31. heart rate before and after intubation

    Measured: Baseline. At 1,2,5 minutes after intubation.

  32. mean arterial pressure before and after intubation

    Measured: baseline.At 1,2,5 minutes after intubation.

  33. Intraoperative Partial Pressure of Arterial Oxygen (PaO₂)

    arterial blood can be drawn from the specimen for examination.

    Measured: During the operation

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

    arterial blood can be drawn from the specimen for examination.

    Measured: During the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start28 Jul 2025
  3. Primary completion22 Dec 2025
  4. Study completion23 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07097584
Sponsor's protocol ID
IRB-2025-841
Status last verified
Aug 2026
First submitted
14 Jul 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share data on ClinicalTrials.gov, and data sharing will be always available.

Questions about this trial

What is this clinical trial studying?

A study testing Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method and Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods in people with Women and Asian, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intubation allocation time (time frame: During induction of general anesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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