Status Approved
First Submitted Date
2019/11/20
Registered Date
2019/12/09
Last Updated Date
2019/11/29
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004514 |
---|---|
Unique Protocol ID | 2019-10-057-001 |
Public/Brief Title | Pupillary light reflex and postoperative delirium |
Scientific Title | Efficacy of pupillary light reflex (PLR) to detect postoperative delirium in elderly patients |
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 |
---|---|
Board Approval Number | 2019-10-057-001 |
Approval Date | 2019-11-19 |
Institutional Review Board Name | Hanyang University Hospital Institutional Review Board |
Institutional Review Board Address | 222-1, Wangsimni-ro, Seongdong-gu, Seoul |
Institutional Review Board Telephone | 02-2290-9653 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Eugene Kim |
Title | Professor |
Telephone | +82-2-2290-8680 |
Affiliation | Hanyang University Seoul Hospital |
Address | 222-1, Wangsimni-ro, Seongdong-gu, Seoul |
Contact Person for Public Queries | |
Name | Soo Yeon Kim |
Title | Fellow |
Telephone | +82-2-2290-8680 |
Affiliation | Hanyang University Seoul Hospital |
Address | 222-1, Wangsimni-ro, Seongdong-gu, Seoul |
Contact Person for Updating Information | |
Name | Soo Yeon Kim |
Title | Fellow |
Telephone | +82-2-2290-8680 |
Affiliation | Hanyang University Seoul Hospital |
Address | 222-1, Wangsimni-ro, Seongdong-gu, Seoul |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2019-12-04 Anticipated | |
Target Number of Participant | 67 | |
Primary Completion Date | 2020-11-30 , Anticipated | |
Study Completion Date | 2020-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hanyang University Seoul Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2019-12-04 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Hanyang University Seoul Hospital |
Organization Type | Medical Institute |
Project ID | 2019-10-057-001 |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Hanyang University Seoul Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Delirium is acute cognitive dysfunction accompanied by sudden changes in consciousness level and unstructured thinking, as well as attention deficit. Patients who develop delirium during hospitalization have increased morbidity and overall medical cost also increases. It has been reported that the incidence of delirium after surgery is higher in elderly patients, and it increases the risk of postoperative complications, prolongs the hospitalization period, intensive care unit hospitalization period, and increases the mortality rate in the long term. The evaluation of mental status and diagnosis of delirium in recovery state is somewhat difficult because of acute postoperative pain, use of analgesics and poor coordination of the patient. Confusion assessment method for intensive care unit (CAM-ICU) is widely used as a standard for the diagnosis of delirium, even for intubated or sedated patients, with high sensitivity and specificity. Although it is relatively simple and does not need much time for evaluation, the reliability is highly dependent on the assessor’s skill. Therefore, the need for an objective assessment method for diagnosing delirium in the recovery state is increasing. Recently, the use of pupillary light reflex has been discussed for assessing mental status in recovery room or transient delirium after general anesthesia. This study was planned to determine the usefulness of the pupillary light reflex for the diagnosis of delirium in the recovery room in elderly patients after general anesthesia. |
---|
8. Study Design
Study Type | Observational Study |
---|---|
Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 67 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Elderly patients undergoing general anesthesia |
Cohort/Group Description Patients aged 65 years or older who are planned hip, knee or spine surgery under general anesthesia will be included. Pupillary light reflex will be measured by a portable infrared pupillometry (PLR-3000, Neuropticsinc., CA, USA) and whether delirium occurs after surgery will be determined using the CAM-ICU (Confusion Assessment Method for the ICU). |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients aged 65 years or older who are planned hip, knee or spine surgery under general anesthesia |
---|---|
Sampling Method | Non-probablity sampling |
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F05.8)Other delirium Anesthesia, General |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 65Year~No Limit |
|
Description - Patients undergoing general anesthesia for hip, knee or spine surgery - Age 65 years old or older - Patients who are above the standard level for each age group on the Mini-Mental State Examination (MMSE) |
|
Exclusion Criteria |
- American Society of Anesthesiologist(ASA) physical status classification IV, V - If normal assessment is difficult because of language barrier, speech disorder, sleep disturbance, mental retardation and dementia - If communication is difficult because of visual or hearing impairment - History of anesthesia and surgery within a month |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Average dilation velocity (ADV) of pupillary light reflex after 30 and 60 minutes of admisson to post-anesthesia care unit (PACU) |
|
Timepoint | 30 and 60 minutes after PACU admission |
|
Primary Outcome(s) 2 | ||
Outcome | Development of delirum in PACU based on CAM-ICU |
|
Timepoint | 30 and 60 minutes after PACU admission |
|
Secondary Outcome(s) 1 | ||
Outcome | Other measurements of pupillary light reflex before and after of general anesthesia |
|
Timepoint | before general anesthesia, right after the admissino to post-anesthesia care unit (PACU), 30 minutes and 1 hour after PACU admission |
|
Secondary Outcome(s) 2 | ||
Outcome | Richmond Agitation-Sedation Scale (RASS) and numeric rating scale (NRS) in PACU |
|
Timepoint | immediately after PACU admission, 10, 20, 30 and 60 minutes after PACU admission |
|
Secondary Outcome(s) 3 | ||
Outcome | Development of postoperative delirium and severity of delirium after PACU discharge |
|
Timepoint | At postoperative day 1, 2 and 3 |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동