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.
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
- Conditions the study is for
- Women, Asian, Thoracic Surgery With One-lung Ventilation
- 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.
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.
- Conditions
- Women, Asian, Thoracic Surgery With One-lung Ventilation
- 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 group | Role | What they receive |
|---|---|---|
| The Down-size Left Double-lumen Endobronchial Tube Group | Experimental | Not 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 Group | Active comparator | Not 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.
Intubation allocation time
The time duration required to complete Double-lumen tube intubation and positioning
Measured: During induction of general anesthesia
Secondary outcomes (34)
Time of laryngoscope insertion
Measured: 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.
Measured: 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).
Measured: 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
Measured: During induction of general anesthesia
Number of intubation attempts
Measured: 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)
Measured: 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.
Measured: 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.
Measured: During induction of general anesthesia
Intubation resistance
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)
Measured: During induction of general anesthesia
Intubation depth
LDLT depth (cm) = 12 + [patient height (cm) × 10-¹
Measured: During induction of general anesthesia
Adverse events during intubation
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: during the operation
Number of intraoperative double-lumen tube adjustments
Measured: During the operation
The incidence of hypoxemia intraoperatively
hypoxemia means arterial oxygen saturation≤90%, and ≥60s
Measured: During the operation
Intraoperative single-lung ventilation time
Measured: 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
Measured: 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
Measured: 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
Measured: after operation,an average of 1-3 days
PACU stay time
Measured: after operation,an average of 60-120 minutes
The incidence of sore throat
Measured: One hour, twenty-four hours, forty-eight hours after surgery
The incidence of postoperative cough
Measured: 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."
Measured: twenty-four hours, forty-eight hours ,thirty days after surgery
Postoperative chest tube removal time
Measured: after operation through study completion,an average of 3-4 days
Length of hospital stay after surgery
Measured: after operation through study completion,an average of 3-7 days
Postoperative 30-day complications
Postoperative 30-day complications by using Clavien-Dindo score
Measured: 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.
Measured: 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
Measured: on postoperative day 1
heart rate before and after intubation
Measured: Baseline. At 1,2,5 minutes after intubation.
mean arterial pressure before and after intubation
Measured: 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.
Measured: During the operation
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.
- First posted31 Jul 2025
- Study start28 Jul 2025
- Primary completion22 Dec 2025
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gu Bin, Zhejiang Cancer Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07097584
- Acronym / sponsor ID
- IRB-2025-841
- Conditions
- Women, Asian, Thoracic Surgery With One-lung Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Down-size Left Double-lumen Endobronchial Tube Group | Experimental | Device: Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method |
| The Regular Left Double-lumen Endobronchial Tube Group | Active comparator | Device: Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Anticipated difficult airway
- Patients with tracheal/left main bronchus anomalies
- Height <152 cm
- Refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional methodDuring 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. | Device | The Down-size Left Double-lumen Endobronchial Tube Group |
| Selecting the size of a Left Double-lumen endobronchialtube according to traditional methodsDuring 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. | Device | The Regular Left Double-lumen Endobronchial Tube Group |
Primary outcome
Intubation allocation time
Time frame: During induction of general anesthesia
The time duration required to complete Double-lumen tube intubation and positioning
34 secondary outcomes
Time of laryngoscope insertion
Time frame: During induction of general anesthesia
Time of double-lumen tube insertion
Time frame: During induction of general anesthesia
Time of successfully positioning of fiberoptic bronchoscope in supine position
Time frame: During induction of general anesthesia
First-pass success rate of intubation
Time frame: During induction of general anesthesia
Number of intubation attempts
Time frame: During induction of general anesthesia
The incidence of Intubation difficulty
Time frame: During induction of general anesthesia
The incidence of air leakage in double-lumen bronchial tubes
Time frame: During induction of general anesthesia
Videolaryngoscope VIDIAC score
Time frame: During induction of general anesthesia
Intubation resistance
Time frame: During induction of general anesthesia
Intubation depth
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)
Time frame: During induction of general anesthesia
Campos atelectasis classification
Time frame: 5 minutes and 20 minutes after the distal port of the double-lumen tube is opened
Accumulated usage times of fiberoptic bronchoscope
Time frame: During the operation
The incidence of misplacement during the operation
Time frame: during the operation
Number of intraoperative double-lumen tube adjustments
Time frame: During the operation
The incidence of hypoxemia intraoperatively
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
Time frame: During the operation
Multiplanar Reconstruction(MPR) of lung CT measurement data
Time frame: after operation,an average of 1-3 days
Bronchial window measurement data
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
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
Time frame: within 30 days after surgery
The incidence of postoperative pulmonary complications
Time frame: within 30 days after surgery
the postoperative recovery
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)
Time frame: During the operation
Intraoperative Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
Time frame: During the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. We will share data on ClinicalTrials.gov, and data sharing will be always available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.