NCT05482230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

July 29, 2022

Last Update Submit

May 13, 2025

Conditions

Keywords

Lateral PositionBronchial occluder

Outcome Measures

Primary Outcomes (1)

  • The incidence of bronchial blocker malposition.

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

    During surgery

Secondary Outcomes (9)

  • The times of bronchial blocker reposition

    During surgery

  • The duration of intubation

    During surgery

  • The pressure of ventilation

    During surgery

  • Intubation-related complications

    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.

  • Postural injuries

    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.

  • +4 more secondary outcomes

Study Arms (2)

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

Procedure: Intubation and bronchial blocker placement performed in lateral position

Intubation and bronchial blocker placement performed in supine position

NO INTERVENTION

Intubation 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.

Interventions

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.

Intubation and bronchial blocker placement performed in lateral position

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jie Zhao

Hangzhou, Zhejiang, A0094, China

Location

Related Publications (13)

  • 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.

    PMID: 29342420BACKGROUND
  • 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.

    PMID: 1472668BACKGROUND
  • 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.

    PMID: 14980953BACKGROUND
  • 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.

    PMID: 26768062BACKGROUND
  • 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.

    PMID: 12598281BACKGROUND
  • 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.

    PMID: 16143578BACKGROUND
  • 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.

    PMID: 20962657BACKGROUND
  • 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.

    PMID: 29384933BACKGROUND
  • 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.

    PMID: 27569229BACKGROUND
  • 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.

    PMID: 30658325BACKGROUND
  • 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.

    PMID: 28093442BACKGROUND
  • 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.

    PMID: 25987271BACKGROUND
  • 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.

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Xiangming Fang, Professor

    First Affilated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intubation and bronchial blocker placement performed in lateral position.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair Professor, Department of Anesthesiology Vice Dean, School of Medicine and and Pharmaceutical sciences Zhejiang University

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 1, 2022

Study Start

December 12, 2022

Primary Completion

May 13, 2024

Study Completion

May 30, 2024

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The patient's relevant vital signs and intubation parameters, etc

Shared Documents
STUDY PROTOCOL

Locations