Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium
Examining the Association Between Perioperative Sleep Disturbance and Postoperative Delirium During Non-cardiac Surgery
1 other identifier
observational
11,927
1 country
1
Brief Summary
The investigators are performing this research study to understand the role of sleep disturbance on the incidence of delirium after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
July 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedJuly 14, 2022
July 1, 2022
2.1 years
July 11, 2022
July 13, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
7 days post surgery
the incidence of survival rate
collection of clinical data in the medical record and follow-up update
1 year
Sleep NRS
sleep numerical rating scale
1 day before the surgery
Sleep NRS
sleep numerical rating scale
7 days post surgery
Sleep NRS
sleep numerical rating scale
baseline
Eligibility Criteria
hospital based group
You may qualify if:
- Geriatric surgical patients ≥65 years old
You may not qualify if:
- Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- China-Japan Friendship Hospitalcollaborator
- Fudan Universitycollaborator
- Beijing Tiantan Hospitalcollaborator
- Peking University First Hospitalcollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Beijing Anzhen Hospitalcollaborator
- Peking University People's Hospitalcollaborator
- Zhejiang Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- The Affiliated Hospital Of Guizhou Medical Universitycollaborator
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- Taihe Hospitalcollaborator
- Zhejiang Provincial People's Hospitalcollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weidong G Mi, PhD
Chinese PLA General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 14, 2022
Study Start
April 1, 2020
Primary Completion
April 30, 2022
Study Completion
July 11, 2022
Last Updated
July 14, 2022
Record last verified: 2022-07