Single-lumen Endotracheal Intubation in ENB-guided Localization and Resection of Pulmonary Nodules
NCT ID: NCT07288255
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
375 participants
INTERVENTIONAL
2023-08-01
2024-12-12
Brief Summary
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• 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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
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.
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
Interventions
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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
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Perioperative data were missing.
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Hecheng Li M.D., Ph.D
Ruijin Hospital, Department of Thoracic Surgery
Locations
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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RJH-TS-202501
Identifier Type: -
Identifier Source: org_study_id