Postoperative Complications Clinical Trial
Official title:
Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications
Verified date | June 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To describe changes in various diurnal patterns in vital values after surgery. These will be analyzed based on whether the patients have complications or no complications.
Status | Completed |
Enrollment | 589 |
Est. completion date | February 12, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Admitted for surgery - Expected time of surgery was more than 2 hours. - Expected post-operative length of stay was more than 2 days. Exclusion Criteria: - Allergy to study materials - Patients with a pacemaker - Patients that were expected to be unable to cooperate with study procedures (for instance a Mini-Mental State Exam(MMSE < 25) |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative complications | Any complication meeting the ICH-GCP serious adverse event(SAE) criteria:
An SAE (...) is defined as any untoward medical occurrence that(...) Results in death Is life-threatening Requires inpatient hospitalization or causes prolongation of existing hospitalization Results in persistent or significant disability/incapacity Requires intervention to prevent permanent impairment or damage (May have caused a congenital anomaly/birth defect - Not relevant) |
From start of continuous monitoring until 12 hours after monitoring stopped. |
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