Status Approved
First Submitted Date
2018/10/16
Registered Date
2019/02/07
Last Updated Date
2019/01/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003472 |
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Unique Protocol ID | CNUHH-2018-121 |
Public/Brief Title | Incidence of postoperative shivering and risk factors |
Scientific Title | Incidence of postoperative shivering and risk factors |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
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 | CNUHH-2018-121 |
Approval Date | 2018-08-24 |
Institutional Review Board Name | Chonnam National University Hwasun Hospital Institutional Review Board/Ethics Committee |
Institutional Review Board Address | 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do |
Institutional Review Board Telephone | 061-379-7598 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seongheon Lee |
Title | Dr. |
Telephone | +82-61-379-8546 |
Affiliation | Chonnam National University Hospital Hwasun Hospital |
Address | 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Seongheon Lee |
Title | Dr. |
Telephone | +82-61-379-8546 |
Affiliation | Chonnam National University Hospital Hwasun Hospital |
Address | 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Republic of Korea |
Contact Person for Updating Information | |
Name | Taehee Pyeon |
Title | Dr. |
Telephone | +82-62-220-6895 |
Affiliation | Chonnam National University Hospital |
Address | 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-08-24 Actual | |
Target Number of Participant | 14000 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chonnam National University Hospital Hwasun Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2018-08-24 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Chonnam National University Hospital Hwasun Hospital |
Organization Type | Medical Institute |
Project ID | CNUHH-2018-121 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University Hospital Hwasun Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Shivering can cause more severe pain in post-operative patients with tension on the surgical site, interrupting patient monitoring , increasing intraocular pressure and intracranial pressure, and increasing oxygen consumption. There are many reasons for the postoperative shivering, but hypothermia is closely related to shivering in anesthetized patients. Hypothermia is induced by core-to-peripheral redistribution of core-temperature caused by vasodiation with sympathetic block in anesthesia, low operating room temperature, and cold intravenous fluid injection. Also, An afferent temperature signal at the anesthetic site is not transmitted to the body temperature control center in the hypothalamus preoptic region, resulting in a temperature regulation dysfunction. But, postoperative shivering can occur in normothremic patients, clear mechanisms are not known. Immediately after anesthesia emergence, the patient hemodynamic status is often unstable and there is high risk of tissue hypoxia due to hypoventilation. At this time, postoperative shivering might be threat of patient’s safety. So, evaluation about incidence and risk factors of postoperative shivering has important role in prevention of postoperative shivering. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Retrospective |
Target Number of Participant | 14000 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Patients who underwent surgery under anesthesia and visited the regular recovery room |
Cohort/Group Description For patients who underwent surgery under anesthesia and visited the regular recovery room, the occurrence of postoperative shivering and possible risk factors will be investigated. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients who underwent surgery under anesthesia and visited the regular recovery room |
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Sampling Method | Non-probability sampling(Purposive sampling): All patients arriving the regular recovery room after anesthesia, who has the complete anesthetic record and postanesthetic recovery record (from 2016 to 2017) |
Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (T81.1)Shock during or resulting from a procedure, NEC Anesthesia Recovery Period: All patients arriving the regular recovery room after anesthesia, who has the complete anesthetic record and postanesthetic recovery record |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description Adult patients arriving the regular recovery room after general anesthesia |
|
Exclusion Criteria |
1. Incomplete data 2. Patients who did not have the abdominal area surgery |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Incidence of postoperative shivering |
|
Timepoint | Staying in the regular recovery room after surgery |
|
Secondary Outcome(s) 1 | ||
Outcome | Risk factors of postoperative shivering |
|
Timepoint | Preoperative and intraoperative period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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