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

Complication of Surgical Procedure Clinical Trial

— WARD-VASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628858
• Other study ID #: H-19086583
• Status: Completed
• Start date: August 17, 2020
• Est. completion date: July 23, 2021

Study information

• Verified date: April 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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'

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 23, 2021
• Est. primary completion date: January 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Eske Kvanner Aasvang

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Readmission		6 months
Other	ICU admission		6 months
Other	Mortality		6 months
Primary	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	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