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Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): a Prospective Randomized Controlled Study

NCT ID: NCT06730984

Last Updated: 2024-12-12

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-12-10

Brief Summary

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This study plans to enroll 148 patients undergoing upper gastrointestinal endoscopic submucosal dissection (ESD). Patients will be randomly divided into a control group (conventional tracheal intubation) and an experimental group (endoscopy-assisted tracheal intubation). Patients meeting the inclusion criteria and not falling under the exclusion criteria will be invited to participate in the study. Upon providing voluntary consent, the research physician will arrange for the patient's inclusion in the study. After signing the informed consent form, the research physician will collect the patient's basic information, medical history, and other details, followed by timing the preoperative preparation period and evaluating postoperative discomfort

Detailed Description

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Conditions

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Tracheal Intubation Endoscopic Submucosal Dissection Endoscopy-Assisted Video Laryngoscope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endoscopy-Assisted Tracheal Intubation

Tracheal Intubation Under Endoscopic Guidance

Group Type EXPERIMENTAL

Endoscopy-Assisted Tracheal Intubation

Intervention Type OTHER

Tracheal Intubation Under Endoscopic Guidance

Traditional Tracheal Intubation

Tracheal Intubation Under Video Laryngoscopy

Group Type ACTIVE_COMPARATOR

Traditional Tracheal Intubation

Intervention Type OTHER

Tracheal Intubation Under Video Laryngoscopy

Interventions

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Endoscopy-Assisted Tracheal Intubation

Tracheal Intubation Under Endoscopic Guidance

Intervention Type OTHER

Traditional Tracheal Intubation

Tracheal Intubation Under Video Laryngoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing endoscopic submucosal dissection (ESD) at Ningbo University Affiliated First Hospital from December 2024 to December 2026.
* Aged between 18 and 75 years.
* Patients who voluntarily agree to participate in the study and sign the informed consent form.

Exclusion Criteria

* Individuals under 18 years of age.
* Patinents unwilling or unable to provide informed consent.
* Patients with severe chronic cardiac or pulmonary disease, or those who have required hospitalization for coronary or cerebrovascular events or radiotherapy within the past 3 months.
* Patients with severe abdominal symptoms such as severe pain, bloating, or nausea.
* Patients with inadequate preoperative preparation.
* Individuals requiring lifelong anticoagulant therapy, those with severe bleeding disorders, or those who have recently taken anticoagulant or antiplatelet medications.
* Pregnant or breastfeeding individuals.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Lei Xu

Role: CONTACT

Phone: +8613486659126

Email: [email protected]

Facility Contacts

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Lei Xu, MD.

Role: primary

Other Identifiers

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2024-139A-02

Identifier Type: -

Identifier Source: org_study_id