- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164836
Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation
The Effect of Suitable Nose Selection Using Rhinoscope on the Incidence and Severity of Epistaxis After Nasotracheal Intubation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anterior rhinoscopy using rhinoscope is a simple way to view the intranasal structure, which allows you to observe the nasal mucosa, the inferior nasal concha, and in some cases, the nasal concha. You can see the nasal septum, polyps, and intranasal malformations. In addition, even when there are no structural abnormalities in the nasal cavity, the wider nasal cavity can be intuitively identified. This information is expected to assist in the selection of nostrils. It has not yet been studied whether anesthesiologists select nasal cavity for nasotracheal intubation using prosthesis can affect the occurrence of epistaxis.
The purpose of this study is to determine whether the selection of a nostril for nasotracheal intubation by rhinoscope affects the incidence and severity of epistaxis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeong-gi Do
-
Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
- Ajou universitiy school of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I or II undergoing surgery under nasotracheal intubation
Exclusion Criteria:
- expected difficult intubation based on history, physical examination, weight.
- bleeding tendency
- past history of nasal surgery
- symptom of difficulty of nasal respiration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: control group
nose selection will be done by random table
|
|
EXPERIMENTAL: rhinoscope group
nose selection will be done by rhinoscopy
|
more suitable nose for nasotracheal intubation will be selected based on the view of rhinoscope.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of epistaxis
Time Frame: immediate after intubation
|
percentage of the development of epistaxis after nasotracheal intubation
|
immediate after intubation
|
incidence of epistaxis
Time Frame: 5 min after intubation
|
percentage of the development of epistaxis after nasotracheal intubation
|
5 min after intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severity of epistaxis4. severe: interfere intubation by blood
Time Frame: immediate after intubation
|
score based on severity of epistaxis will be recorded. 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx |
immediate after intubation
|
severity of epistaxis
Time Frame: 5 min after intubation
|
score based on severity of epistaxis will be recorded. 1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx |
5 min after intubation
|
Collaborators and Investigators
Investigators
- Principal Investigator: yun jeong chae, PhD MD, Ajou University School of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-MED-OBS-19-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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