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

NCT06730984 | Not Yet Recruiting

• 1 other identifier: 2024-139A-02
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Tracheal Intubation; Endoscopic Submucosal Dissection; Endoscopy-Assisted; Video Laryngoscope

Outcome Measures

Primary Outcomes (1)

• preoperative preparation time

  the time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity

  10 mins

Secondary Outcomes (2)

• The time to view the vocal cords (TVVC)

  1 min

• The time to advance the tracheal tube into trachea (TATT)

  1 min

Study Arms (2)

Endoscopy-Assisted Tracheal Intubation

EXPERIMENTAL

Tracheal Intubation Under Endoscopic Guidance

Other: Endoscopy-Assisted Tracheal Intubation

Traditional Tracheal Intubation

ACTIVE COMPARATOR

Tracheal Intubation Under Video Laryngoscopy

Other: Traditional Tracheal Intubation

Interventions

Endoscopy-Assisted Tracheal Intubation OTHER

Tracheal Intubation Under Endoscopic Guidance

Endoscopy-Assisted Tracheal Intubation

Traditional Tracheal Intubation OTHER

Tracheal Intubation Under Video Laryngoscopy

Traditional Tracheal Intubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Location

Central Study Contacts

Lei Xu

CONTACT

+8613486659126; xulei22@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)