- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362797
Clinical Application of Right Visual Double Lumen Tube in Thoracoscopic Surgery for Adult Patients
Comparison of Clinical Application of Right Visual Double Lumen Tube and Right Ordinary Double Lumen Tube in Thoracoscopic Surgery for Adult Patients
This clinical trial aims to understand whether a visual double-lumen intubation tube can improve the first-attempt success rate and reduce complications compared to a standard double-lumen tube. The trial primarily aims to answer the following questions:
Does a double-lumen tube improve the first-attempt success rate?
Does a visual double-lumen tube reduce the likelihood of obstruction of the right upper lobe bronchial opening?
Does a visual double-lumen tube require fewer adjustments during surgery?
Do patients with visual double-lumen tubes experience fewer perioperative complications compared to those with standard double-lumen tubes?
Participants will:
Use a visual double-lumen tube partially and a standard double-lumen tube partially.
Record the perioperative status of all patients.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heng Wen
- Phone Number: +8615158080827
- Email: zyyywenheng@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- The First Affiliated Hospital, Zhejiang University School of Medicine,
-
Contact:
- Heng Wen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: at least 18 years old, gender is not limited.
- American Anesthesiologists Association (ASA) Grade I-III;
- Elective Video-Assisted Thoracoscopic Lobectomy.
- Informed consent of the patient or family member.
- People who are willing to accept perioperative visits.
Exclusion Criteria:
- Patients with contraindications for right double-lumen tube insertion (such as right bronchial tumor).
- The patient has known tracheobronchial anatomical abnormalities
- Patients previously diagnosed or suspected of having airway difficulty.
- Patients who need rapid sequence induction.
- Patients requiring emergency surgery
- Patients who have undergone thoracic surgery, systemic infection or suspected tuberculosis in the past four weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: visual double-lumen tube group
Lung-isolation thoracoscopic surgery using a right-side visual double-lumen tube.
|
A visible double-lumen tube on the right side
Other Names:
|
|
Active Comparator: Non-visual dual-lumen tube (ordinary dual-lumen tube) group
Lung isolation thoracoscopic surgery was performed with fiberoptic bronchoscopy assistance using a standard double-lumen tube on the right side (non-visual double-lumen tube).
|
The standard double-lumen tube on the right side was positioned with the aid of a fiberoptic bronchoscope.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary purpose
Time Frame: After anesthesia induction, the laryngoscope is inserted and the timing begins until the endotracheal tube position is confirmed. The endotracheal tube is then fixed, and mechanical ventilation is initiated (approximately 10 minutes).
|
To study whether the right visual double lumen tube can improve the success rate of initial intubation compared with the right ordinary double lumen tube.
|
After anesthesia induction, the laryngoscope is inserted and the timing begins until the endotracheal tube position is confirmed. The endotracheal tube is then fixed, and mechanical ventilation is initiated (approximately 10 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary purposes
Time Frame: After the endotracheal tube is secured, the patient is ventilated by a ventilator, and ventilation of the right single lung is initiated (lasting approximately 2-3 minutes).
|
Compare the obstruction of the right upper bronchial opening in the two groups of patients.
|
After the endotracheal tube is secured, the patient is ventilated by a ventilator, and ventilation of the right single lung is initiated (lasting approximately 2-3 minutes).
|
|
Intraoperative cannulation position adjustment
Time Frame: The entire surgery (approximately 1-3 hours).
|
Compare the number of times the endotracheal intubation position needed to be adjusted and the total adjustment time between the two groups of patients.
|
The entire surgery (approximately 1-3 hours).
|
|
postoperative complications
Time Frame: From the end of surgery to the patient's discharge (2-3 days).
|
The postoperative complications of the two groups of patients were compared.
|
From the end of surgery to the patient's discharge (2-3 days).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZJU2025C144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Thoracoscopic Surgery
-
The Second Affiliated Hospital of Chongqing Medical...CompletedThoracoscopic Surgery | EsketamineChina
-
Hitit UniversityAnkara Ataturk Sanatorium Training and Research HospitalCompletedVideo-assisted Thoracoscopic SurgeryTurkey
-
Burcu Bozdogan TuysuzCompletedVideo-Assisted Thoracoscopic SurgeryTurkey
-
Seoul National University HospitalUnknownVideo Assisted Thoracoscopic SurgeryKorea, Republic of
-
Imam Abdulrahman Bin Faisal UniversityUnknownVideo-assisted Thoracoscopic SurgerySaudi Arabia
-
ZhangyiRecruitingThoracoscopic Surgery | Nerve BlockChina
-
Institut Mutualiste MontsourisUnknownSegmentectomy | Video-assisted Thoracoscopic Surgery (VATS)France
-
Ataturk UniversityCompletedVATS | Video Assisted Thoracoscopic SurgeryTurkey (Türkiye)
-
Shanghai Pulmonary Hospital, Shanghai, ChinaNot yet recruitingIpsilateral Shoulder Pain | Video-Assisted Thoracoscopic SurgeryChina
-
Xueying YangUnknownLobectomy | Subxiphoid Uniportal Video-assisted Thoracoscopic SurgeryChina
Clinical Trials on visible double-lumen tube
-
University of Texas Southwestern Medical CenterCompletedSingle Lung Ventilation | Double Lumen Endotracheal TubeUnited States
-
International Institute of Rescue Research and...Unknown
-
Medical University of SilesiaCompletedPredictive Value of Tests | Intubation;DifficultPoland
-
Lazarski UniversityCompletedIntubation; Difficult or Failed | Difficult Airway | Intubation;DifficultPoland
-
Rambam Health Care CampusCompletedEndotracheal Intubation | Airway Management | One Lung Ventilation
-
Seoul National University HospitalUnknownPreventing Blood Leakage of Bronchial CuffKorea, Republic of
-
Zhejiang UniversityNot yet recruiting
-
Rennes University HospitalCompletedPancreaticoduodenectomy | Digestive System Surgical ProcedureFrance
-
University Medical Centre LjubljanaUnknown
-
Ajou University School of MedicineCompletedIntubation;DifficultKorea, Republic of