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Completed

NCT Number: NCT06730984

Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD)

This study plans to enroll 132 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

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Key information

Conditions

Tracheal Intubation Endoscopic Submucosal Dissection Endoscopy-Assisted Video Laryngoscope

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients 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.

Treatment and study plan

Endoscopy-Assisted Tracheal Intubation

Other

Tracheal Intubation Under Endoscopic Guidance

Traditional Tracheal Intubation

Other

Tracheal Intubation Under Video Laryngoscopy

Primary outcomes

  1. preoperative preparation time

    Time frame: 30 minutes

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

Secondary outcomes

  1. The time to view the vocal cords (TVVC)

    Time frame: 10 minutes

    the time from inserting the tracheal tube into mouth to the operator view the the entire vocal cords

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

    Time frame: 10 minutes

    the time from viewing the entire vocal cords to insert the tracheal tube into trachea successfully

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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