NCT07014345

Brief 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. 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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

December 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Last Updated

August 14, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

May 22, 2025

Last Update Submit

August 10, 2025

Conditions

Keywords

Double-lumen tubelateral position intubationfirst-attempt success ratethoracic surgery

Outcome Measures

Primary Outcomes (1)

  • Successful First-Pass Intubation

    The primary outcome was the success rate of the first DLT intubation attempt.

    Periprocedural

Secondary Outcomes (9)

  • No. of intubation attempts

    Periprocedural

  • Intubation time

    Periprocedural

  • Interval before surgery

    Periprocedural

  • p-Peak

    Periprocedural

  • Flexible bronchoscope usage

    Periprocedural

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

DLT placement performed in lateral position

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (5)

  • 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.

    PMID: 38167877BACKGROUND
  • Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.

    PMID: 19752725BACKGROUND
  • Brodsky JB. Lung separation and the difficult airway. Br J Anaesth. 2009 Dec;103 Suppl 1:i66-75. doi: 10.1093/bja/aep262.

    PMID: 20007992BACKGROUND
  • Yang 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.

    PMID: 23975566BACKGROUND
  • Saji 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.

    PMID: 35461558BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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

May 22, 2025

First Posted

June 11, 2025

Study Start

December 1, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 14, 2025

Record last verified: 2025-06

Locations