- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06605989
Nostril Side on Epistaxis
The Effect of Nostril Side on Epistaxis During Nasotracheal Intubation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized controlled study was approved by the IRB of our institute.
Patients requiring nasotracheal intubation will be screened for eligibility for the study. Then, patients will be randomized to one of two groups; (Group I: tube will be inserted through the left nostril and advanced into the oral cavity / Group II: tube will be inserted through the right nostril and advanced into the oral cavity). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via the nostril, which is assigned to each patient according to the group, approximately 3-4 cm. Next, an anesthesiologist will advance the tube into the oral cavity. After the tube is placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check the occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtaining all data, investigators will analyze the incidence of epistaxis and its severity between the two groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jung-Man Lee, M.D., Ph.D.
- Phone Number: +82-2-870-2513
- Email: jungman007@gmail.com
Study Locations
-
-
Dongjak-gu
-
Seoul, Dongjak-gu, South Korea, 07061
- Recruiting
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
-
Contact:
- Jung-Man Lee, M.D.,Ph.D.
- Phone Number: +82-2-870-2513
- Email: jungman007@gmail.com
-
Principal Investigator:
- Jung-Man Lee, M.D.,Ph.D.
-
-
Gangnam-gu
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Seoul, Gangnam-gu, South Korea, 06273
- Recruiting
- Gangnam Severance Hospital
-
Contact:
- Jiwon Lee, M.D.,Ph.D.
- Phone Number: +82-10-5279-8275
- Email: belief705@gmail.com
-
Principal Investigator:
- Jiwon Lee, M.D.,Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult patients requiring nasotracheal intubation for elective surgery
Exclusion Criteria:
- refuse to participate in the study
- severe deformity in the nose
- current severe epistaxis
- cannot insert the tube into a specific nostril side due to any reason
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: left nostril side
For nasotracheal intubation, the nasal RAE tube will be inserted through the left nostril and advanced into the oral cavity.
|
For nasotracheal intubation, the nasal RAE tube will be first inserted through the left nostril for patients in the left nostril side arm.
For nasotracheal intubation, the nasal RAE tube will be first inserted through the right nostril for patients in the right nostril side arm.
|
|
Experimental: right nostril side
For nasotracheal intubation, the nasal RAE tube will be inserted through the right nostril and advanced into the oral cavity.
|
For nasotracheal intubation, the nasal RAE tube will be first inserted through the left nostril for patients in the left nostril side arm.
For nasotracheal intubation, the nasal RAE tube will be first inserted through the right nostril for patients in the right nostril side arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
epistaxis
Time Frame: during nasotracheal intubation
|
epistaxis due to nasotracheal intubation
|
during nasotracheal intubation
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jung-Man Lee, M.D.,Ph.D., Seoul National University College of Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2024-0025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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