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Completed

NCT Number: NCT04628858

Wireless Assessment of Respiratory and Circulatory Distress in 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'

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Active therapy withdrawn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

Treatment and study plan

Primary outcomes

  1. Physiologic abnormal vital signs - Cumulative duration

    Time frame: From inclusion until 4 days or discharge

    Cumulative duration of physiologic vital signs within certain thresholds outside normalcy

Secondary outcomes

  1. Physiologic abnormal vital signs - Episodes of sustained duration

    Time frame: 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 outcomes

  1. Any serious adverse events

    Time frame: 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

    Time frame: 6 months

  3. ICU admission

    Time frame: 6 months

  4. Mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Eske Kvanner Aasvang

Other

Registry information

Official study title

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

Acronym: WARD-VASC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2020
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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