Intratracheal IntubationNCT06182371
Effectiveness of Detachment of the Breathing Circuit on the Rate of DLT Malposition After Postural Change
A study testing Disengage the breathing circuit in people with Intratracheal Intubation and Patient Positioning, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intratracheal Intubation, Patient Positioning
- What is being tested?
- Disengage the breathing circuit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 8 Dec 2025
- 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
- ASA I-II elective surgery for patients
- Patients undergoing thoracic surgery requiring a left-sided double-lumen endobronchial tube;
- Sign the informed consent form for this clinical study.
Who cannot join
- Mouth opening <3cm;
- History of previous difficult intubation;
- Patients with diseases of the upper respiratory tract and main bronchi;
- Cardiac insufficiency;
- People with liver dysfunction;
- Renal insufficiency;
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- Previous stroke;
- Patients with severe obstructive ventilation dysfunction;
- Bronchial asthma or airway hyperresponsiveness;
- Patients who have participated in other clinical studies in the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, S, 250021
About this study
Official title: Effectiveness of Detachment of the Breathing Circuit on the Rate of the Double-lumen Endotracheal Tube Malposition After the Change of Position in Patients Undergoing Thoracic Surgery: a Randomized Controlled Trial
The goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. The study is to investigate: whether detaching the breathing circuit in patients undergoing thoracic surgery would reduce the rate of double-lumen endobronchial tube malposition, the incidence of postoperative pulmonary complications, and improve patient outcomes.
Participants will be randomly divided into a disconnected breathing circuit group and a breathing circuit connected group and after entering the operating room, the intravenous access will be opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation, arterial pressure, and end-expiratory carbon dioxide will be monitored. Anesthesia induction will be performed by an anesthesiologist, and then the double-lumen endobronchial tube will be inserted under laryngoscopic guidance. Will the catheter be delivered to the expected depth, the double-lumen endobronchial tube will be connected to the anesthesia machine for mechanical ventilation.
Researchers will compare the malposition rate of the double-lumen endobronchial tube when the patient transitions from the supine to lateral decubitus position, the effect of single-lung ventilation, oxygen saturation at 5 and 10 minutes after single-lung ventilation, and postoperative recovery time.
- Conditions
- Intratracheal Intubation, Patient Positioning
- Being tested
- Disengage the breathing circuit
- Keywords
- Double-Lumen Endobronchial Tube, Positional changes, Disengage, Breathing circuit, Malposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disengage the breathing circuitBehavioural
Disengage the breathing circuit when the position of the patient undergoing thoracic surgery changes
| Study group | Role | What they receive |
|---|---|---|
| Disengagement of the breathing circuit | Experimental | When the patient's position is changed from the supine position to the lateral decubitus position, the anesthesiologist disengages the breathing circuit. Receives: Behavioral: Disengage the breathing circuit |
| Connect the breathing circuit | No intervention | When the patient's position is changed from the supine position to the lateral decubitus position, the anesthesiologist maintains the normal connection of the breathing line. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malposition rate of a double-lumen endobronchial tube
Double-lumen endobronchial tube malposition is more than 5 mm away from the optimal position of the catheter. Severe malposition is the inability to see the upper left or lower left bronchial opening in the left common bronchi: the right upper lobe bronchial opening cannot be seen clearly in the right common bronchi; or bronchial cuffs more than 50% in the trachea.
Measured: Immediately after a change in body position
Secondary outcomes (3)
Effects of lung collapse
If the lung on the operative side is completely atrophied and the surgical field is satisfied, it indicates that the degree of lung atrophy is good. The surgeon will score the quality of lung collapse using a four-point ordinal scale (1= extremelypoor-no collapse of lung; 2= poor-partial collapse of lung with interference with surgical exposure; 3= good-total collapse, but the lung still had some residual air; and 4= excellent-complete collapse of lung with perfect surgical exposure).
Measured: 5 and 10 minutes after the pleura opens
Blood oxygen saturation
An oxygen saturation below 94% is considered oxygen insufficiency
Measured: 1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation
PACU length of stay
The patient is awake and conscious
Measured: The time from the transfer to the PACU to the transfer out to ward, an average of an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start16 May 2025
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intratracheal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention: After the insertion of a DLT under general anesthesia, the anesthesiologist disengaged the breathing circuit when the patient transitioned from the supine to the lateral position.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Meng Lv, Shandong Provincial Hospital
- Investigators
- Jin Bao Mao, Ph.D., Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182371
- Sponsor's protocol ID
- MLv
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lv S, Lv M, Du W, Zou Z, Zheng K, Qu J, Han X, Mao J. Does ventilator circuit disconnection during lateral positioning reduces the rate of double-lumen endotracheal tube displacement in thoracic surgery? a study protocol for a randomized controlled trial. Trials. 2026 Feb 28;27(1):272. doi: 10.1186/s13063-026-09567-w.
PubMed 41761244
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Detachment of the Breathing Circuit on the Rate of the Double-lumen Endotracheal Tube Malposition After the Change of Position in Patients Undergoing Thoracic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06182371
- Acronym / sponsor ID
- MLv
- Conditions
- Intratracheal Intubation, Patient Positioning
- Keywords
- Double-Lumen Endobronchial Tube, Positional changes, Disengage, Breathing circuit, Malposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 16 May 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 26 Dec 2023 (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 goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. The study is to investigate: whether detaching the breathing circuit in patients undergoing thoracic surgery would reduce the rate of double-lumen endobronchial tube malposition, the incidence of postoperative pulmonary complications, and improve patient outcomes.
Participants will be randomly divided into a disconnected breathing circuit group and a breathing circuit connected group and after entering the operating room, the intravenous access will be opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation, arterial pressure, and end-expiratory carbon dioxide will be monitored. Anesthesia induction will be performed by an anesthesiologist, and then the double-lumen endobronchial tube will be inserted under laryngoscopic guidance. Will the catheter be delivered to the expected depth, the double-lumen endobronchial tube will be connected to the anesthesia machine for mechanical ventilation.
Researchers will compare the malposition rate of the double-lumen endobronchial tube when the patient transitions from the supine to lateral decubitus position, the effect of single-lung ventilation, oxygen saturation at 5 and 10 minutes after single-lung ventilation, and postoperative recovery time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention: After the insertion of a DLT under general anesthesia, the anesthesiologist disengaged the breathing circuit when the patient transitioned from the supine to the lateral position.
| Arm | Type | Receives |
|---|---|---|
| Disengagement of the breathing circuit | Experimental | Behavioral: Disengage the breathing circuitWhen the patient's position is changed from the supine position to the lateral decubitus position, the anesthesiologist disengages the breathing circuit. |
| Connect the breathing circuit | No intervention | –When the patient's position is changed from the supine position to the lateral decubitus position, the anesthesiologist maintains the normal connection of the breathing line. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II elective surgery for patients
- Patients undergoing thoracic surgery requiring a left-sided double-lumen endobronchial tube;
- Sign the informed consent form for this clinical study.
Key exclusion criteria (10 listed)
- Mouth opening <3cm;
- History of previous difficult intubation;
- Patients with diseases of the upper respiratory tract and main bronchi;
- Cardiac insufficiency;
- People with liver dysfunction;
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 |
|---|---|---|
| Disengage the breathing circuitDisengage the breathing circuit when the position of the patient undergoing thoracic surgery changes | Behavioural | Disengagement of the breathing circuit |
Primary outcome
Malposition rate of a double-lumen endobronchial tube
Time frame: Immediately after a change in body position
Double-lumen endobronchial tube malposition is more than 5 mm away from the optimal position of the catheter. Severe malposition is the inability to see the upper left or lower left bronchial opening in the left common bronchi: the right upper lobe bronchial opening cannot be seen clearly in the right common bronchi; or bronchial cuffs more than 50% in the trachea.
3 secondary outcomes
Effects of lung collapse
Time frame: 5 and 10 minutes after the pleura opens
Blood oxygen saturation
Time frame: 1 minute and 5 minutes after the change of position；1 minute, 5 minutes and 10 minutes after single-lung ventilation
PACU length of stay
Time frame: The time from the transfer to the PACU to the transfer out to ward, an average of an hour
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 29 Apr 2026.
- Derived from this study: PubMed 41761244Lv S, Lv M, Du W, Zou Z, Zheng K, Qu J, Han X, Mao J. Does ventilator circuit disconnection during lateral positioning reduces the rate of double-lumen endotracheal tube displacement in thoracic surgery? a study protocol for a randomized controlled trial. Trials. 2026 Feb 28;27(1):272. doi: 10.1186/s13063-026-09567-w.
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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.
Jin Bao Mao, Ph.D. principal investigator
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disengage the breathing circuit in people with Intratracheal Intubation and Patient Positioning, run by Shandong Provincial 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 3 inclusion and 10 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 29 Apr 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?
Malposition rate of a double-lumen endobronchial tube (time frame: Immediately after a change in body position). 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 NCT06182371, which also lists 1 linked publication.
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 29 Apr 2026.