An observational study in Complication of Surgical Procedure, Complication of Anesthesia and Respiratory Complication, sponsored by Eske Kvanner Aasvang. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Eske Kvanner Aasvang · Observational
Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities.
After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward.
Monitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke.
Vital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'
40 patients admitted for elective or subacute vascular surgical intervention, as noted in the inclusion criteria, will be included on the day before their surgical procedure.
Exclusion Criteria:
Physiologic abnormal vital signs - Cumulative duration
Cumulative duration of physiologic vital signs within certain thresholds outside normalcy
Time frame: From inclusion until 4 days or discharge
Physiologic abnormal vital signs - Episodes of sustained duration
Episodes of sustained duration of physiologic vital signs within certain thresholds outside normalcy, with different minimum durations
Time frame: From inclusion until 4 days or discharge
Any serious adverse events
In accordance with ICH-GCP: 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
Time frame: 30 days
Readmission
Time frame: 6 months
ICU admission
Time frame: 6 months
Mortality
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Eske Kvanner Aasvang