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AnesthesiaNCT05482230

Application of Tracheal Intubation in Lateral Position in Thoracic Surgery

A study testing Intubation and bronchial blocker placement performed in lateral position in people with Anesthesia and Tracheal Intubation, run by xiangming fang 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

This study investigated the incidence of bronchial blocker malposition in the lateral versus supine position and evaluated the effectiveness of lateral placement. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anesthesia, Tracheal Intubation, Thoracic Surgery
What is being tested?
Intubation and bronchial blocker 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
306 participants
Where
1 siteChina
Study dates
12 Dec 2022to 30 May 2024
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The inclusion criteria :

  • 80 Years<age ≥18 years;
  • American Society of Anesthesiologists (ASA) physical status I-III;
  • Undergo thoracic surgery requiring one-lung ventilation.

The exclusion criteria were:

  • Risk of difficult intubation based on preoperative assessment (maximum mouth opening <3 cm, body mass index >30 kg/m2, limited neck movement, Mallampati grade IV, or main airway stenosis);
  • Right upper bronchus originating at or above the tracheal carina;
  • Plan to undergo bronchial sleeve resection, right upper lobectomy, or non-intubated thoracic surgery;
  • Evidence or symptoms of acute lung or airway infection;
  • History of thoracic surgery;
  • Prior thoracic radiotherapy or chemotherapy;
  • Preoperative upper extremity pain;
  • Severe mental illness or difficulty with communication.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jie Zhao

    Hangzhou, Zhejiang, A0094

Other trials in China

About this study

Official title: Lung Isolation With a Bronchial Blocker Placed in the Lateral Position for Patients Undergoing Thoracic Surgery: a Multicenter, Randomized Clinical Trial

This study investigated the incidence of bronchial blocker malposition in the lateral versus supine position and evaluated the effectiveness of lateral placement.

Read the detailed description

Routine thoracic surgery anesthesia requires that endotracheal intubation be performed with the patient in the supine position; the patient subsequently needs to be placed in a lateral position through the cooperation of the anesthetist, theatre nurse, and surgeon. Achieving this change in position is time-consuming and likely to result in adverse events, such as loss of the anesthetic airway and arteriovenous catheter, hemodynamic fluctuations, and malposition of the BB which adversely affect anesthesia management and postoperative recovery. For patients with hypertensive heart disease, the risk of cardiovascular and cerebrovascular accidents increases during the perioperative period .

Therefore, we conducted a prospective, randomized, controlled, multi-center study to evaluate the ease, efficacy, and safety of video laryngoscopy-guided intubation and bronchial blocker placement performed in lateral position.

Being tested
Intubation and bronchial blocker placement performed in lateral position
Keywords
Lateral Position, Bronchial occluder

What participants receive

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

  • Intubation and bronchial blocker 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, both endotracheal intubation and bronchial blocker placement were performed while the patient remained in the lateral position.

Study groups in NCT05482230
Study groupRoleWhat they receive
Intubation and bronchial blocker placement performed in lateral positionExperimentalIn the lateral position group, patients were positioned laterally (as required for surgery) before anesthesia induction. After anesthesia induction, both endotracheal intubation and bronchial blocker placement were performed while the patient remained in the lateral position.
Receives: Procedure: Intubation and bronchial blocker placement performed in lateral position
Intubation and bronchial blocker placement performed in supine positionNo interventionIntubation and the placement of a bronchial blocker are 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.

  1. The incidence of bronchial blocker malposition.

    The incidence of bronchial blocker malposition in two groups S and L

    Measured: During surgery

Secondary outcomes (9)

  1. The times of bronchial blocker reposition

    The times of bronchial blocker reposition in lateral group and supine group

    Measured: During surgery

  2. The duration of intubation

    The duration of intubation, including the time for single-lumen tube intubation, the time for bronchial blocker placement, and the total intubation time (single-lumen tube intubation plus bronchial blocker placement)

    Measured: During surgery

  3. The pressure of ventilation

    The pressure of ventilation during mask ventilation, two-lung ventilation (TLV) and one-lung ventilation(OLV)

    Measured: During surgery

  4. Intubation-related complications

    Intubation-related complications, including airway injury, dental injury, sore throat, and hoarseness

    Measured: During surgery, after the patient regained full consciousness and before discharge from the post-anesthesia care unit, on the day after surgery, and 2 weeks postoperatively.

  5. Postural injuries

    Postural injuries were defined as new-onset injuries not present before surgery but occurring within the first 2 weeks postoperatively, including neuropathies, vasculopathies, and musculoskeletal injuries

    Measured: These complications were assessed at three time points: after the patient regained full consciousness and before discharge from the post-anesthesia care unit, on the day after surgery, and 2 weeks postoperatively.

  6. Lung collapse grade

    When the chest wall was opened, the lung collapse was graded as follows: fully collapsed lung, non-collapsed lung with no visible ventilation, or fully ventilated lung

    Measured: During surgery

  7. Perioperative vital signs

    Perioperative vital signs, including mean arterial pressure (MAP), heart rate (HR), and SpO2

    Measured: Immediately after arrival at operating room; Before single lumen tube intubation; After single lumen tube intubation ; One-lung ventilation; Before single lumen tube extubating; 5 minutes after single lumen tube extubating.

  8. Hypoxemia

    Hypoxemia was defined as a drop in oxygen saturation (SpO2) below 92%

    Measured: During surgery

  9. The satisfaction scores

    The satisfaction scores of patients, nurses and surgeons. Satisfaction scores were used a 0-10 scale (10 = very satisfied).

    Measured: Perioperative period

Timeline

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

  1. First posted1 Aug 2022
  2. Study start12 Dec 2022
  3. Primary completion13 May 2024
  4. Study completion30 May 2024

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intubation and bronchial blocker placement performed in lateral position.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482230
Sponsor's protocol ID
2015299
Status last verified
May 2025
First submitted
29 Jul 2022
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The patient's relevant vital signs and intubation parameters, etc

Publications

  • Lewis JW Jr, Serwin JP, Gabriel FS, Bastanfar M, Jacobsen G. The utility of a double-lumen tube for one-lung ventilation in a variety of noncardiac thoracic surgical procedures. J Cardiothorac Vasc Anesth. 1992 Dec;6(6):705-10. doi: 10.1016/1053-0770(92)90056-d.

    PubMed 1472668

  • Komatsu R, Nagata O, Sessler DI, Ozaki M. The intubating laryngeal mask airway facilitates tracheal intubation in the lateral position. Anesth Analg. 2004 Mar;98(3):858-61, table of contents. doi: 10.1213/01.ane.0000100741.46539.6b.

    PubMed 14980953

  • Goh SY, Thong SY, Chen Y, Kong AS. Efficacy of intubation performed by trainees on patients in the lateral position. Singapore Med J. 2016 Sep;57(9):503-6. doi: 10.11622/smedj.2015165. Epub 2015 Nov 13.

    PubMed 26768062

  • Dimitriou V, Voyagis GS, Iatrou C, Brimacombe J. Flexible lightwand-guided intubation using the intubating laryngeal mask airway in the supine, right, and left lateral positions in healthy patients by experienced users. Anesth Analg. 2003 Mar;96(3):896-898. doi: 10.1213/01.ANE.0000048839.12552.50.

    PubMed 12598281

  • Biswas BK, Agarwal B, Bhattacharyya P, Badhani UK, Bhattarai B. Intubating laryngeal mask for airway management in lateral decubitus state: comparative study of right and left lateral positions. Br J Anaesth. 2005 Nov;95(5):715-8. doi: 10.1093/bja/aei226. Epub 2005 Sep 2.

    PubMed 16143578

  • Takenaka I, Aoyama K, Iwagaki T, Kadoya T. Efficacy of the Airway Scope on tracheal intubation in the lateral position: comparison with the Macintosh laryngoscope. Eur J Anaesthesiol. 2011 Mar;28(3):164-8. doi: 10.1097/EJA.0b013e328340c368.

    PubMed 20962657

  • Jin Y, Ying J, Zhang K, Fang X. Endotracheal intubation under video laryngoscopic guidance during upper gastrointestinal endoscopic surgery in the left lateral position: A randomized controlled trial. Medicine (Baltimore). 2017 Dec;96(52):e9461. doi: 10.1097/MD.0000000000009461.

    PubMed 29384933

  • Li H, Wang W, Lu YP, Wang Y, Chen LH, Lei LP, Fang XM. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial. Chin Med J (Engl). 2016 Sep 5;129(17):2045-9. doi: 10.4103/0366-6999.189069.

    PubMed 27569229

  • Lai HC, Wu ZF. Easier double-lumen tube placement using real-time video laryngoscopy and wireless video fiberoptic bronchoscopy. J Clin Anesth. 2019 Aug;55:132-133. doi: 10.1016/j.jclinane.2018.12.023. Epub 2019 Jan 15. No abstract available.

    PubMed 30658325

  • Birring SS, Brew J, Kilbourn A, Edwards V, Wilson R, Morice AH. Rococo study: a real-world evaluation of an over-the-counter medicine in acute cough (a multicentre, randomised, controlled study). BMJ Open. 2017 Jan 16;7(1):e014112. doi: 10.1136/bmjopen-2016-014112.

    PubMed 28093442

  • Saini S, Bhanot A, Kamal K, Bansal T. An improvised head support to facilitate endotracheal intubation in the lateral position. Acta Anaesthesiol Taiwan. 2015 Sep;53(3):109-11. doi: 10.1016/j.aat.2015.04.001. Epub 2015 Apr 24. No abstract available.

    PubMed 25987271

  • Almeida C, Freitas MJ, Brandao D, Assuncao JP. [Use of bronchial blocker in emergent thoracotomy in presence of upper airway hemorrhage, and cervical spine fracture: a difficult decision]. Braz J Anesthesiol. 2018 Jul-Aug;68(4):408-411. doi: 10.1016/j.bjan.2017.09.004. Epub 2018 Jan 17.

    PubMed 29342420

  • Li H, Chu L, Ye H, Zhang Y, Li M, Hua Y, Zhang J, Hu H, Wen T, Zhao J, Wan H, Huang L, Lou Y, Tang J, Yan Z, Duan G, Wu J, Wang C, Lu Y, Shen X, Huang C, Song C, Wang Y, Zeng C, Xie G, Fang X. Lung isolation with a bronchial blocker placed in the lateral position for patients undergoing thoracic surgery: A multicenter, randomized clinical trial. J Clin Anesth. 2025 Jun;104:111869. doi: 10.1016/j.jclinane.2025.111869. Epub 2025 May 13.

    PubMed 40367865

Questions about this trial

What is this clinical trial studying?

A study testing Intubation and bronchial blocker placement performed in lateral position in people with Anesthesia and Tracheal 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?

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 16 May 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 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?

The incidence of bronchial blocker malposition. (time frame: During surgery). 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 NCT05482230, which also lists 13 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 16 May 2025.

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