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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06730984
Enrollment
132
Registered
2024-12-12
Start date
2024-12-10
Completion date
2025-12-30
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

OTHEREndoscopy-Assisted Tracheal Intubation

Tracheal Intubation Under Endoscopic Guidance

Tracheal Intubation Under Video Laryngoscopy

Sponsors

Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
preoperative preparation time30 minutesthe time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity

Secondary

MeasureTime frameDescription
The time to view the vocal cords (TVVC)10 minutesthe 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)10 minutesthe time from viewing the entire vocal cords to insert the tracheal tube into trachea successfully

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026