Status Approved
First Submitted Date
2021/02/02
Registered Date
2021/02/17
Last Updated Date
2021/02/02
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005902 |
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Unique Protocol ID | PC21OISI0014 |
Public/Brief Title | A study on the diffference of the cricothyroid membrane identification between difficult airway and normal airway |
Scientific Title | Accuracy of surface landmark palpation for identification of the cricothyroid membrane in female patients who preoperatively predicted difficult airway 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 | PC21OISI0014 |
Approval Date | 2021-01-28 |
Institutional Review Board Name | Institutional Review Board of Eunpyeong St. Mary's Hospital, The Catholic University of Korea |
Institutional Review Board Address | 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea |
Institutional Review Board Telephone | 02-2030-3715 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Soyeon Lee |
Title | Fellow |
Telephone | +82-2-2030-3862 |
Affiliation | The Catholic University of Korea, Eunpyeong St. Mary's Hospital |
Address | 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Soyeon Lee |
Title | Fellow |
Telephone | +82-2-2030-3862 |
Affiliation | The Catholic University of Korea, Eunpyeong St. Mary's Hospital |
Address | 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Soyeon Lee |
Title | Fellow |
Telephone | +82-2-2030-3862 |
Affiliation | The Catholic University of Korea, Eunpyeong St. Mary's Hospital |
Address | 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-02-15 Anticipated | |
Target Number of Participant | 60 | |
Primary Completion Date | 2022-01-26 , Anticipated | |
Study Completion Date | 2022-01-26 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | The Catholic University of Korea, Eunpyeong St. Mary's Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-02-15 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | The Catholic University of Korea, Eunpyeong St. Mary's Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea, Eunpyeong St. Mary's Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Hypothesis: Palpation of the cricothyroid membrane in female patients who are preoperatively expected to have difficult airway would be less accurate than in female patients with normal airway. The first endpoint of the study is to compare the accuracy of surface landmark palpation for cricothyroid membrane identification in female patients who are preoperatively predicted to have difficult airway and normal airway. Cricothyroidotomy is a way of emergent airway puncture to establish a patent airway during life-threatening situations such as "Can't intubate, can't ventilate (CICV)" or "Can't intubate, can't oxygenate (CICO)". Clinicians need to get familiar with relevant anatomy and develop the ability to identify the cricothyroid membrane (CTM). One way to improve familiarity with the anatomy is to palpate the structures of the anterior neck regularly when examining patients. The boundaries of the CTM are the thyroid cartilage superiorly, the cricoid cartilage inferiorly, and the cricothyroideus muscles laterally on both sides. Identifying the CTM is more confusing in women than in men because laryngeal prominence is less prominent. To get over this hardship, bedside ultrasound has been proposed as a method for identifying the cricothyroid membrane (CTM). In this study, we will examine the patients' airway before the induction of anesthesia and analyze the diffference of the CTM identification accuracy between difficult airway and normal airway, |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 60 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label difficult airway group |
Cohort/Group Description Based on a physical examination(Palpation) : If any of "3-3-2 rules" are applicable ** 3-3-2 rules : (a) Inter-incisor distance <3 finger breadths (b) Hyoid-to-mental distance < 3 finger breadths (c) Thyroid-to-hyoid distance <2 finger breadths |
|
Cohort/ Group 2 |
Cohort/Group Label normal airway group |
Cohort/Group Description Based on a physical examination(Palpation) : If none of "3-3-2 rules" are applicable ** 3-3-2 rules : (a) Inter-incisor distance <3 finger breadths (b) Hyoid-to-mental distance < 3 finger breadths (c) Thyroid-to-hyoid distance <2 finger breadths |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Female patients who undergo surgery under general anesthesia or regional anesthesia in the Eunpyeong St. Mary's Hospital. |
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Sampling Method | Among female patients who undergo surgery under general anesthesia or regional anesthesia in the Eunpyeong St. Mary's Hospital during the study period, 30 patients who are preoperatively predicted to have difficult airway and 30 patients with normal airway will be enrolled prospectively. |
Condition(s)/Problem(s) |
Not Applicable-Etc
airway management |
Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~74Year |
|
Description 1) Sex: Female 2) Adults: over 19 and under 75 years old 3) ASA(American Society of Anesthesiologists) physical status 1 or 2 |
|
Exclusion Criteria |
1) Patients who disagree with the participation in this study 2) Patients with cognitive impairments, who can not understand this study 3) Pregnant women 4) Sex: Male 3) Age under 19 or over 75 4) ASA(American Society of Anesthesiologists) physical status ≥3 5) Patients with pathologic lesion in the neck 6) Patients who undergo neck surgeries |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Diffference of the cricothyroid membrane identification between difficult airway and normal airway |
|
Timepoint | Before induction of an anesthesia |
|
Secondary Outcome(s) 1 | ||
Outcome | Ultrasonographic identification of the cricothyroid membrane |
|
Timepoint | Before induction of an anesthesia |
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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