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

NCT07288255 | Completed

• 1 other identifier: RJH-TS-202501
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Nodule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain score

  Perioperative

• Semiquantitative cough strength score

  Perioperative

Study Arms (2)

SL-DL group

SHAM COMPARATOR

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

SL group

ACTIVE COMPARATOR

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

Interventions

Single lumen PROCEDURE

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

SL group

single-lumen to double-lumen 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).

SL-DL group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ruijin Hospital, Department of Thoracic Surgery

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 17, 2025
• Study Start: August 1, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: With publication
• 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.

Locations

CN (1)