Clinical trial NCT04628858: Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study
Official title: Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical Procedure
Complication of Anesthesia
Respiratory Complication
Circulatory; Complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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'


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Copenhagen University Hospital
* Patients with Peripheral Arteriel Disease(PAD)
* Patients undergoing open infraligamentary revascularization
* Emergency or subacute surgery
* Admission the day before surgery, and expected length of stay more than 2 days.

Exclusion Criteria:

* Patient expected not to cooperate
* Patients with dementia or not able to give informed consent
* Patient allergic to plaster, plastic or silicone
* Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
* Patients in isolation
* Active therapy withdrawn
* Patients previously included in the other study branches
* Patients with \>20 mmHg in difference in systolic blood pressure between the two arms.
* Expected discharge within less than 24 hours from possible inclusion

Primary outcomes:
measure: Physiologic abnormal vital signs - Cumulative duration
timeFrame: From inclusion until 4 days or discharge
Secondary outcomes:
measure: Physiologic abnormal vital signs - Episodes of sustained duration
timeFrame: From inclusion until 4 days or discharge
Other outcomes:
measure: Any serious adverse events
timeFrame: 30 days
measure: Readmission
timeFrame: 6 months
measure: ICU admission
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang
role: STUDY_DIRECTOR
References: