Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study

Completed

• Conditions: Respiratory Complication; Complication of Surgical Procedure; Circulatory; Complications; Complication of Anesthesia

• Registration Number: NCT04628858
• Lead Sponsor: Eske Kvanner Aasvang

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'

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-17
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Primary Completion: 2021-01-23
• Study Completion: 2021-07-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physiologic abnormal vital signs - Cumulative duration	From inclusion until 4 days or discharge	Cumulative duration of physiologic vital signs within certain thresholds outside normalcy

Secondary Outcome Measures

Name	Time	Method
Physiologic abnormal vital signs - Episodes of sustained duration	From inclusion until 4 days or discharge	Episodes of sustained duration of physiologic vital signs within certain thresholds outside normalcy, with different minimum durations

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark