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

December 15, 2025 updated by: Hecheng Li M.D., Ph.D, Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of postoperative complications
Time Frame: Within 30 days postoperatively
Postoperative complications included the incidence of complications such as pneumonia, atelectasis, pneumothorax, air leakage, and pleural effusion.
Within 30 days postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Perioperative
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
Time Frame: Perioperative
Cough strength was evaluated using the semiquantitative cough strength score (SCSS), graded from 0 (weak) to 5 (strong)
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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