Vital Values at Circadian Markers in Postoperative Patients

Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05347784

Enrollment

589

Registered

2022-04-26

Start date

2018-02-20

Completion date

2021-02-12

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Dysrhythmia, Postoperative Complications

Keywords

Postoperative physiology, Vital signs

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Postoperative complications	From start of continuous monitoring until 12 hours after monitoring stopped.	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)

Countries

Denmark

Outcome results