Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study (WARD-VASC)

Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study

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'

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Primary group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic abnormal vital signs - Cumulative duration	Cumulative duration of physiologic vital signs within certain thresholds outside normalcy	From inclusion until 4 days or discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From inclusion until 4 days or discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		6 months
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	30 days
Readmission		6 months
ICU admission		6 months

Collaborators and Investigators

• Sponsor: Eske Kvanner Aasvang
• Investigators: Study Director: Eske K Aasvang, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): January 23, 2021
• Study Completion (Actual): July 23, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H-19086583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No