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

N

Ningbo No. 1 Hospital

Status

Not yet enrolling

Conditions

Tracheal Intubation
Endoscopic Submucosal Dissection
Video Laryngoscope
Endoscopy-Assisted

Treatments

Other: Endoscopy-Assisted Tracheal Intubation
Other: Traditional Tracheal Intubation

Study type

Interventional

Funder types

Other

Identifiers

NCT06730984
2024-139A-02

Details and patient eligibility

About

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

Enrollment

132 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

132 participants in 2 patient groups

Endoscopy-Assisted Tracheal Intubation
Experimental group
Description:
Tracheal Intubation Under Endoscopic Guidance
Treatment:
Other: Endoscopy-Assisted Tracheal Intubation
Traditional Tracheal Intubation
Active Comparator group
Description:
Tracheal Intubation Under Video Laryngoscopy
Treatment:
Other: Traditional Tracheal Intubation

Trial contacts and locations

1

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Central trial contact

Lei Xu

Data sourced from clinicaltrials.gov

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