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

Sponsor
Eske Kvanner Aasvang (Other)
Overall Status
Completed
CT.gov ID
NCT04628858
Collaborator
(none)
40
1
11.2
3.6

Study Details

Study Description

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'

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study
Actual Study Start Date :
Aug 17, 2020
Actual Primary Completion Date :
Jan 23, 2021
Actual Study Completion Date :
Jul 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Primary group

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Other Outcome Measures

  1. Any serious adverse events [30 days]

    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

  2. Readmission [6 months]

  3. ICU admission [6 months]

  4. Mortality [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Eske Kvanner Aasvang

Investigators

  • Study Director: Eske K Aasvang, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eske Kvanner Aasvang, Dr. Med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04628858
Other Study ID Numbers:
  • H-19086583
First Posted:
Nov 16, 2020
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Apr 27, 2022