Tracheal IntubationNCT06730984
Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD)
A study testing Endoscopy-Assisted Tracheal Intubation and Traditional Tracheal Intubation in people with Tracheal Intubation and Endoscopic Submucosal Dissection, run by Ningbo No. 1 Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tracheal Intubation, Endoscopic Submucosal Dissection, Endoscopy-Assisted
- What is being tested?
- Endoscopy-Assisted Tracheal Intubation and Traditional Tracheal Intubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
About this study
Official title: Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): A Prospective Randomized Controlled Study
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
- Conditions
- Tracheal Intubation, Endoscopic Submucosal Dissection, Endoscopy-Assisted, Video Laryngoscope
- Being tested
- Endoscopy-Assisted Tracheal Intubation, Traditional Tracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy-Assisted Tracheal IntubationOther
Tracheal Intubation Under Endoscopic Guidance
Traditional Tracheal IntubationOther
Tracheal Intubation Under Video Laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy-Assisted Tracheal Intubation | Experimental | Tracheal Intubation Under Endoscopic Guidance Receives: Other: Endoscopy-Assisted Tracheal Intubation |
| Traditional Tracheal Intubation | Active comparator | Tracheal Intubation Under Video Laryngoscopy Receives: Other: Traditional Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative preparation time
the time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity
Measured: 30 minutes
Secondary outcomes (2)
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
Measured: 10 minutes
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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Dec 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730984
- Sponsor's protocol ID
- 2024-139A-02
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06730984
- Acronym / sponsor ID
- 2024-139A-02
- Conditions
- Tracheal Intubation, Endoscopic Submucosal Dissection, Endoscopy-Assisted, Video Laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopy-Assisted Tracheal Intubation | Experimental | Other: Endoscopy-Assisted Tracheal IntubationTracheal Intubation Under Endoscopic Guidance |
| Traditional Tracheal Intubation | Active comparator | Other: Traditional Tracheal IntubationTracheal Intubation Under Video Laryngoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy-Assisted Tracheal IntubationTracheal Intubation Under Endoscopic Guidance | Other | Endoscopy-Assisted Tracheal Intubation |
| Traditional Tracheal IntubationTracheal Intubation Under Video Laryngoscopy | Other | Traditional Tracheal Intubation |
Primary outcome
preoperative preparation time
Time frame: 30 minutes
the time from Initiate Anesthesia Induction to Insert the Therapeutic Endoscope into the Oral Cavity
2 secondary outcomes
The time to view the vocal cords (TVVC)
Time frame: 10 minutes
The time to advance the tracheal tube into trachea (TATT)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy-Assisted Tracheal Intubation and Traditional Tracheal Intubation in people with Tracheal Intubation and Endoscopic Submucosal Dissection, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative preparation time (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.