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

Not Applicable

Not yet recruiting

• Conditions: Tracheal Intubation; Endoscopic Submucosal Dissection; Endoscopy-Assisted; Video Laryngoscope

• Registration Number: NCT06730984
• Lead Sponsor: Ningbo No. 1 Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study Start: 2024-12-10
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12-08
• Study Completion: 2026-12-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
preoperative preparation time	10 mins	the time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity

Secondary Outcome Measures

Name	Time	Method
The time to view the vocal cords (TVVC)	1 min	the time from inserting the tracheal tube into mouth to the operator view the the entire vocal cords
The time to advance the tracheal tube into trachea (TATT)	1 min	the time from viewing the entire vocal cords to insert the tracheal tube into trachea successfully

Trial Locations

Locations (1)

the First Affiliated Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China