Double Lumen Tube IntubationNCT07014345
Double-Lumen Tube Intubation in the Lateral Position Versus the Supine Position on First-Attempt Success Rate
A study testing DLT placement performed in lateral position in people with Double Lumen Tube Intubation, run by xiangming fang at 1 site in China.
Trial summary
The aim of this clinical trial is to find out the first success rate of double lumen intubation in the lateral position in thoracic surgery, it will also find out the safety of double lumen tube intubation in the lateral position. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Double Lumen Tube Intubation
- What is being tested?
- DLT placement performed in lateral position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Nov 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- need for DLT intubation with elective unilateral thoracoscopic surgery
- age 18-65 years
- American Society of Anesthesiologists (ASA) grade of I or II
- no serious cardiopulmonary disease
Who cannot join
- aged <18 years or >65 years
- body mass index >30 kg/m2
- cognitive dysfunction and inability to assume the required body position
- previous cervical vertebrae and expected difficult airway (e.g., Mallampati airway grade of III, IV, or higher, maximum mouth opening <3 finger widths, nail-chin distance <6 cm)
- admission to the intensive care unit after surgery and without follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Lumen Tube Intubation in the Lateral Position Versus the Supine Position on First-Attempt Success Rate Among Patients Undergoing Thoracic Surgery: A Prospective, Randomized, Controlled, Multi-center Trial
The aim of this clinical trial is to find out the first success rate of double lumen intubation in the lateral position in thoracic surgery, it will also find out the safety of double lumen tube intubation in the lateral position. The trial aims to answer the following key questions
Does intubation in lateral position improve the first-time success rate of double-lumen intubation compared with in the supine position? What medical problems can participants experience during double lumen tube intubation in the lateral position? The researchers will compare double lumen intubation in the lateral position vs supine position to see if the position is effective in the success rate of double lumen intubation.
Read more
Participants will
Use the supine or lateral position during intubation
- Conditions
- Double Lumen Tube Intubation
- Being tested
- DLT placement performed in lateral position
- Keywords
- Double-lumen tube, lateral position intubation, first-attempt success rate, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLT placement performed in lateral positionProcedure or surgery
In the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, Double lumen tube placement was performed while the patient remained in the lateral position.
| Study group | Role | What they receive |
|---|---|---|
| DLT placement performed in lateral position | Experimental | In the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, Double lumen tube placement was performed while the patient remained in the lateral position. Receives: Procedure: DLT placement performed in lateral position |
| DLT placement performed in supine position | No intervention | A double-lumen tube is typically carried out with the patient in the supine position, which is a standard procedure in thoracic surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful First-Pass Intubation
The primary outcome was the success rate of the first DLT intubation attempt.
Measured: Periprocedural
Secondary outcomes (9)
No. of intubation attempts
Number of patients who were successfully intubated on any attempt
Measured: Periprocedural
Intubation time
Defined as from the time when the laryngoscope passed between the patient's lips until the use of a fiberoptic bronchoscope to confirm the correct positioning of the DLT.
Measured: Periprocedural
Interval before surgery
Defined as the time interval between the admission of patients in the operating room and the start of surgery.
Measured: Periprocedural
p-Peak
peak inspiratory pressure(p-Peak) during mask ventilation, total-lung ventilation(TLV) and one-lung ventilation(OLV)
Measured: Periprocedural
Flexible bronchoscope usage
the frequency of use of flexible bronchoscope
Measured: Periprocedural
the incidence of DLT malposition
the incidence of DLT malposition observed by flexible bronchoscope (DLT malposition was defined as movement >1.0 cm to correct the DLT position)
Measured: Periprocedural
early intubation-related complications
early intubation-related complications (dental injury; hypoxemia; laryngospasm; bronchospasm; airway trauma; arrhythmia, including the salve of ventricular premature beats, ventricular fibrillation, and ventricular tachycardia; oral mucosal injury; and esophageal intubation)
Measured: Periprocedural
postoperative complications
postoperative complications (sore throat, GRBAS scale, upper-arm discomfort, and nerve injury)
Measured: Periprocedural
satisfaction scores.
0 points: dissatisfied, 1 point: satisfied, 2 points: very satisfied.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Dec 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Why it stopped: Similar studies have been conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Double Lumen Tube IntubationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- xiangming fang
- Sponsor type
- University, hospital or other
- Collaborators
- Red Cross Hospital, Hangzhou, China, The First Affiliated Hospital of Guangzhou Medical University, Central People's Hospital of Zhanjiang, The Central Hospital of Lishui City
- Responsible party
- Sponsor-investigator, xiangming fang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014345
- Sponsor's protocol ID
- Intubation
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Kim H, Seol T, Han SH, Kim H, Hwang JY. A bench study on the prevention of lung-to-lung aspiration with double-lumen endobronchial tubes and bronchial blockers. Sci Rep. 2024 Jan 2;14(1):187. doi: 10.1038/s41598-023-50792-z.
PubMed 38167877Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.
PubMed 19752725Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
PubMed 20007992Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.
PubMed 23975566Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
PubMed 35461558
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Lumen Tube Intubation in the Lateral Position Versus the Supine Position on First-Attempt Success Rate Among Patients Undergoing Thoracic Surgery: A Prospective, Randomized, Controlled, Multi-center Trial
- ClinicalTrials.gov ID
- NCT07014345
- Acronym / sponsor ID
- Intubation
- Conditions
- Double Lumen Tube Intubation
- Keywords
- Double-lumen tube, lateral position intubation, first-attempt success rate, thoracic surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Similar studies have been conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- xiangming fangUniversity, hospital or other
- Collaborators
- Red Cross Hospital, Hangzhou, China, The First Affiliated Hospital of Guangzhou Medical University, Central People's Hospital of Zhanjiang, The Central Hospital of Lishui City
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 11 Jun 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 aim of this clinical trial is to find out the first success rate of double lumen intubation in the lateral position in thoracic surgery, it will also find out the safety of double lumen tube intubation in the lateral position. The trial aims to answer the following key questions
Does intubation in lateral position improve the first-time success rate of double-lumen intubation compared with in the supine position? What medical problems can participants experience during double lumen tube intubation in the lateral position? The researchers will compare double lumen intubation in the lateral position vs supine position to see if the position is effective in the success rate of double lumen intubation.
Participants will
Use the supine or lateral position during intubation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLT placement performed in lateral position | Experimental | Procedure: DLT placement performed in lateral positionIn the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, Double lumen tube placement was performed while the patient remained in the lateral position. |
| DLT placement performed in supine position | No intervention | –A double-lumen tube is typically carried out with the patient in the supine position, which is a standard procedure in thoracic surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- need for DLT intubation with elective unilateral thoracoscopic surgery
- age 18-65 years
- American Society of Anesthesiologists (ASA) grade of I or II
- no serious cardiopulmonary disease
Key exclusion criteria (5 listed)
- aged <18 years or >65 years
- body mass index >30 kg/m2
- cognitive dysfunction and inability to assume the required body position
- previous cervical vertebrae and expected difficult airway (e.g., Mallampati airway grade of III, IV, or higher, maximum mouth opening <3 finger widths, nail-chin distance <6 cm)
- admission to the intensive care unit after surgery and without follow-up
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 |
|---|---|---|
| DLT placement performed in lateral positionIn the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, Double lumen tube placement was performed while the patient remained in the lateral position. | Procedure or surgery | DLT placement performed in lateral position |
Primary outcome
Successful First-Pass Intubation
Time frame: Periprocedural
The primary outcome was the success rate of the first DLT intubation attempt.
9 secondary outcomes
No. of intubation attempts
Time frame: Periprocedural
Intubation time
Time frame: Periprocedural
Interval before surgery
Time frame: Periprocedural
p-Peak
Time frame: Periprocedural
Flexible bronchoscope usage
Time frame: Periprocedural
the incidence of DLT malposition
Time frame: Periprocedural
early intubation-related complications
Time frame: Periprocedural
postoperative complications
Time frame: Periprocedural
satisfaction scores.
Time frame: Periprocedural
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Results publication: PubMed 38167877Kim H, Seol T, Han SH, Kim H, Hwang JY. A bench study on the prevention of lung-to-lung aspiration with double-lumen endobronchial tubes and bronchial blockers. Sci Rep. 2024 Jan 2;14(1):187. doi: 10.1038/s41598-023-50792-z.
- Results publication: PubMed 19752725Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.
- Results publication: PubMed 20007992Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.
- Results publication: PubMed 23975566Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.
- Results publication: PubMed 35461558Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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 DLT placement performed in lateral position in people with Double Lumen Tube Intubation, run by xiangming fang 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 5 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: withdrawn, as of the sponsor's last update on 14 Aug 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Successful First-Pass Intubation (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014345, which also lists 5 linked publications.
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 14 Aug 2025.