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

NCT04628858 | Completed

• 1 other identifier: H-19086583
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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'

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physiologic abnormal vital signs - Episodes of sustained duration

  From inclusion until 4 days or discharge

Other Outcomes (4)

• Any serious adverse events

  30 days

• Readmission

  6 months

• ICU admission

  6 months

Study Arms (1)

Primary group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eske Kvanner Aasvang: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Troponin-T

Study Officials

• Eske K Aasvang

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Med.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: August 17, 2020
• Primary Completion: January 23, 2021
• Study Completion: July 23, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)