NCT07755722

Brief Summary

This study evaluated how simple external airway maneuvers affect the alignment of the left main bronchus during placement of a left-sided double-lumen endotracheal tube. Adults undergoing elective thoracic surgery requiring one-lung ventilation were enrolled. During double-lumen tube placement, a fiberoptic bronchoscope was used to continuously view the airway. Each participant underwent three sequential maneuvers: rightward displacement of the trachea, turning the head 45 degrees to the right, and turning the head 45 degrees to the left. The investigators measured how far the opening of the left main bronchus moved on the bronchoscopic image and whether it crossed the center of the image. The purpose of the study was to determine how these maneuvers change airway alignment and whether they may help guide a left-sided double-lumen tube toward the left main bronchus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

Study Start

First participant enrolled

April 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Double-Lumen Endotracheal TubeHead RotationOne-Lung VentilationFiberoptic BronchoscopyAirway Management

Outcome Measures

Primary Outcomes (1)

  • Midline Crossing of the Left Main Bronchus

    Midline crossing was defined as a change in the position of the left main bronchus from the left side to the right side of the midline of the bronchoscopic image following each airway maneuver. The position of the left main bronchus was assessed using real-time fiberoptic bronchoscopy with the bronchoscope maintained 2 cm proximal to the carina. Midline crossing was recorded as a binary outcome (yes/no) for each maneuver.

    During the airway maneuver, immediately after each maneuver was applied

Secondary Outcomes (1)

  • Relative Horizontal Displacement of the Left Main Bronchus

    During the airway maneuver, immediately after each maneuver was applied

Study Arms (1)

Airway Maneuver Group

EXPERIMENTAL

Participants underwent three airway maneuvers in a predefined sequence during left-sided double-lumen tube placement: right tracheal displacement, 45° right head turn, and 45° left head turn. The airway and head position were returned to neutral between maneuvers. Bronchoscopic alignment and horizontal displacement of the left main bronchus were assessed during each maneuver.

Procedure: Right Tracheal DisplacementProcedure: Right Head Turn ManeuverProcedure: Left Head Turn Maneuver

Interventions

The participant's head was rotated 45° to the right from the neutral position. Bronchoscopic alignment and horizontal displacement of the left main bronchus were assessed during the maneuver. The head was subsequently returned to the neutral position.

Airway Maneuver Group

A lateral force was applied externally at the left cricothyroid level to displace the trachea toward the right. The force was increased until maximal bronchoscopic displacement was observed. Peak applied force was recorded using a digital force gauge. Bronchoscopic alignment and horizontal displacement of the left main bronchus were assessed during the maneuver.

Airway Maneuver Group

The participant's head was rotated 45° to the left from the neutral position. Bronchoscopic alignment and horizontal displacement of the left main bronchus were assessed during the maneuver. The head was subsequently returned to the neutral position.

Airway Maneuver Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective thoracic surgery requiring lung isolation with a left-sided double-lumen endotracheal tube
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Provided written informed consent

You may not qualify if:

  • Known severe cervical spine pathology or cervical instability
  • History of cervical spine surgery
  • Significant anatomical abnormalities of the upper airway
  • Head or neck malignancy or obstructing airway neoplasm
  • Presence of a tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Study Officials

  • Chien-Kun Ting, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants underwent the same three airway maneuvers in a predefined sequence: right tracheal displacement, 45° right head turn, and 45° left head turn. The airway and head position were returned to neutral before each subsequent maneuver. Bronchoscopic alignment and horizontal displacement of the left main bronchus were assessed during each maneuver.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start

April 10, 2024

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article will be available upon reasonable request to the corresponding author, subject to institutional and ethical requirements.

Time Frame
Data will be available beginning after publication of the study results. No predetermined end date is planned.
Access Criteria
De-identified individual participant data underlying the published results will be available to researchers who submit a reasonable request to the corresponding author. Requests should include the purpose of the proposed research and the data requested. Access will be subject to approval by the study investigators and applicable institutional and ethical requirements.

Locations