Single-lumen Endotracheal Intubation in ENB-guided Localization and Resection of Pulmonary Nodules

Application of 'One-stop' Single-lumen Endotracheal Intubation for Electromagnetic Navigation Bronchoscopy-guided Localization and Resection of Pulmonary Nodules: a Single-center Retrospective Cohort Analysis

The goal of this clinical study is to evaluate the practicality, safety, and feasibility of a 'one-stop' single-lumen (SL) endotracheal intubation strategy for patients undergoing wedge resection of early-stage lung nodules with electromagnetic navigation bronchoscopy (ENB)-guided localization. The main question it aims to answer is:

• Is the 'one-stop' SL strategy, where an SL tube is used continuously from ENB localization through surgery, non-inferior to the conventional practice of switching from an SL to a double-lumen (DL) tube in terms of perioperative outcomes and complication rates?

Participants scheduled for ENB-guided localization followed by wedge resection will be managed with either the proposed 'one-stop' SL intubation method or the conventional SL-to-DL conversion method. Researchers will compare key perioperative indicators and patient outcomes between the two groups.

Study Overview

• Status: Completed
• Conditions: Lung Nodule
• Intervention / Treatment: Procedure: single-lumen to double-lumen; Procedure: Single lumen

Detailed Description

With increased health awareness and the widespread use of low-dose CT for lung cancer screening, early detection rates have risen. For early-stage non-small cell lung cancer, sub-lobar resection (segmentectomy or wedge resection) is now strongly recommended for peripheral nodules ≤2 cm without nodal involvement, as per recent landmark trials and NCCN guidelines. However, for wedge resection, precise localization and minimization of pulmonary function impairment still pose challenges for thoracic surgeons. Therefore, achieving effective resection while preserving lung function as much as possible necessitates precise localization of pulmonary nodules.

The CT-guided hook-wire localization method is currently the most frequently used technique in clinical practice for pulmonary nodule localization, but patients may experience significant pain and there is a risk of dislodgement of the hook wire during patient transfer or positioning before surgery. Furthermore, CT localization results in a high risk of pneumothorax and bleeding. The emergence of electromagnetic navigation bronchoscopy (ENB) not only alleviates patient discomfort but also reduces surgical time and lowers the risk of complications.

Typically, during ENB-guided localization, a single-lumen (SL) endotracheal tube is used under general anesthesia and subsequently replaced with a double-lumen (DL) endotracheal tube after the procedure. However, the conversion from SL to DL could potentially elevate the possibility of airway damage and anesthetic complications. Therefore, in patients undergoing wedge resection with ENB-guided localization, the investigators propose a 'one-stop' SL strategy, in which an SL tube is employed throughout the entire process from localization to surgery.

This study aimed to evaluate the practicality of utilizing SL endotracheal intubation for the entire process of ENB-guided localization and subsequent surgical procedure, referred as 'one-stop' SL. By comparing the conventional practice of the transition from SL to DL intubation with our proposed 'one-stop' SL intubation method based on perioperative indicators and patient outcomes, the investigators hope to determine whether the 'one-stop' SL strategy is safe and feasible clinically.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who had pulmonary nodules and underwent video-assisted thoracoscopic surgery (VATS) lung surgery with ENB-guided nodule localization

Exclusion Criteria:

• Patients who received non-intubated anesthesia or underwent wedge resection combined with lobectomy or segmentectomy were excluded.
• Perioperative data were missing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: SL-DL group; After the ENB-guided localization procedure, patients in the single-lumen to double-lumen (SL-DL) group had their single-lumen endotracheal tubes were replaced with double-lumen tubes, enabling thoracoscopic surgery to be performed in the lateral decubitus position under one-lung ventilation (OLV).	Procedure: single-lumen to double-lumen; patients in the single-lumen to double-lumen (SL-DL) group had their single-lumen endotracheal tubes were replaced with double-lumen tubes, enabling thoracoscopic surgery to be performed in the lateral decubitus position under one-lung ventilation (OLV).
Active Comparator: SL group; The patients in the single-lumen (SL) group did not undergo tube replacement. Throughout the surgery, anesthesiologists adjusted the tidal volume to optimize the surgical field for the thoracic surgeons.	Procedure: Single lumen; patients in the single-lumen (SL) group did not undergo tube replacement. Throughout the surgery, anesthesiologists adjusted the tidal volume to optimize the surgical field for the thoracic surgeons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complications	Postoperative complications included the incidence of complications such as pneumonia, atelectasis, pneumothorax, air leakage, and pleural effusion.	Within 30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain score was assessed using the Visual Analog Scale (VAS), a 10-point scale where 0 represents "no pain" and 10 represents "the worst pain imaginable," with higher scores indicating more severe pain.	Perioperative
Semiquantitative cough strength score	Cough strength was evaluated using the semiquantitative cough strength score (SCSS), graded from 0 (weak) to 5 (strong)	Perioperative

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: September 28, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RJH-TS-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data
• IPD Sharing Time Frame: With publication
• IPD Sharing Access Criteria: Interested investigators will be required to submit a formal letter of intent outlining research aims, rationale, and approach. Furthermore, documentation of local IRB approval, including a description of type of review, should be submitted with the data request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No