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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Endoscopic Submucosal Dissection; Tracheal Intubation; Video Laryngoscope; Endoscopy-Assisted
• Intervention / Treatment: Other: Endoscopy-Assisted Tracheal Intubation; Other: Traditional Tracheal Intubation

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Xu; Phone Number: +8613486659126; Email: xulei22@163.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • The First Affiliated Hospital of Ningbo University
      • Contact: Lei Xu, MD.; Phone Number: +86-13486659126; Email: xulei22@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopy-Assisted Tracheal Intubation; Tracheal Intubation Under Endoscopic Guidance	Other: Endoscopy-Assisted Tracheal Intubation; Tracheal Intubation Under Endoscopic Guidance
Active Comparator: Traditional Tracheal Intubation; Tracheal Intubation Under Video Laryngoscopy	Other: Traditional Tracheal Intubation; Tracheal Intubation Under Video Laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative preparation time	the time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity	10 mins

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-139A-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No