Status Approved
First Submitted Date
2020/05/20
Registered Date
2020/05/28
Last Updated Date
2020/05/19
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005067 |
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Unique Protocol ID | HYUH 2020-03-028-002 |
Public/Brief Title | Selection a suitable nostril for nasotracheal intubation |
Scientific Title | Selection a suitable nostril for nasotracheal intubation |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | HYUH 2020-03-028-002 |
Approval Date | 2020-05-21 |
Institutional Review Board Name | Institutional Review Board of Hanyang University Seoul Hospital |
Institutional Review Board Address | 222-1, Wangsimni-ro, Seongdong-gu, Seoul |
Institutional Review Board Telephone | 02-2220-0673 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hyunyoung Lim |
Title | Assistant professor |
Telephone | +82-2-2290-8680 |
Affiliation | Hanyang University Seoul Hospital |
Address | 222-1, Wangsimni-ro. Seongdong-cu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Hyunyoung Lim |
Title | Assistant professor |
Telephone | +82-2-2290-8680 |
Affiliation | Hanyang University Seoul Hospital |
Address | 222-1, Wangsimni-ro. Seongdong-cu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Hyunyoung Lim |
Title | Assistant professor |
Telephone | +82-2-2290-8680 |
Affiliation | Hanyang University Seoul Hospital |
Address | 222-1, Wangsimni-ro. Seongdong-cu, Seoul, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-01 Anticipated | |
Target Number of Participant | 138 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hanyang University Seoul Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-06-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Hanyang University Seoul Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hanyang University Seoul Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | In head and neck surgery or dental surgery, the insertion of naso-tracheal tube may be necessary to clearify the operational view. At this time, the naso-tracheal tube is inserted into one nostril, and side effects such as nasal bleeding or septal damage may occur in this process. The nasal septal deviation has a various incidence even in asymptomatic people. The naso-tracheal intubation in the usual method for patients with asymptomatic nasal septal deviation may be performed at a narrower nostril, increasing the incidence of side effects or failing to intubating. This study is aimed to investigate wheather side effects and failure rates are related to nasal septal deviation and the occurrence of nasal septal deviation after extubation when a nostril is selected in usual method to perform intubation of naso-tracheal tube. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Prospective |
Target Number of Participant | 138 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label The group of patients undergoing naso-tracheal intubation with a more breathable nostril. |
Cohort/Group Description When a nostril is selected for naso-tracheal intubation, the intubation is performed on a better breathable nostril according to the subjective judgment of the patient by blocking one nostril and inducing nasal breathing. We observe nasal bleeding during naso-tracheal intubation and failure rate of tracheal intubation. |
|
Cohort/ Group 2 |
Cohort/Group Label The group of patients undergoing naso-tracheal intubation with a less breathable nostril. |
Cohort/Group Description When a nostril is selected for naso-tracheal intubation, the intubation is performed on the opposite side of the better breathable nostril according to the subjective judgment of the patient by blocking one nostril and inducing nasal breathing. We observe nasal bleeding during naso-tracheal intubation and failure rate of tracheal intubation. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients aged 19 to under 75 who undergo head and neck surgery at Hanyang University Seoul Hostpital |
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Sampling Method | The two groups are assigned randomly. |
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C76.0)Malignant neoplasm of head, face and neck Neoplasms [C04] Wounds and Injuries [C26] |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~74Year |
|
Description -Patients who require intubation of a naso-tracheal tube during general anesthesia for head and neck surgery -Adult patients aged 19 to under 75 -I, II and III of American Society of Anesthesiologist(ASA) physical status classification -Patients who have previously agreed to the study |
|
Exclusion Criteria |
-Patients with a history of difficult tracheal intubation -Patients who are expected to have difficulty in tracheal intubation or mannual mask ventilation -Patients who are pregnant |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Safety | |
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Primary Outcome(s) 1 | ||
Outcome | Nasal bleeding |
|
Timepoint | After induction of anesthesia |
|
Primary Outcome(s) 2 | ||
Outcome | Failure rate of naso-tracheal intubation |
|
Timepoint | After induction of anesthesia |
|
Secondary Outcome(s) 1 | ||
Outcome | The level of resistance when the naso-tracheal tube passes through the nasal cavity. |
|
Timepoint | After induction of anesthesia |
|
Secondary Outcome(s) 2 | ||
Outcome | Number of attempts at naso-tracheal intubation |
|
Timepoint | After induction of anesthesia |
|
Secondary Outcome(s) 3 | ||
Outcome | Degree of nasal septal curvature in radiology of the head and neck. |
|
Timepoint | Before and after surgery |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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