Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards

Launched by UNIVERSITY HOSPITAL BISPEBJERG AND FREDERIKSBERG · Dec 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how continuous monitoring of vital signs can help detect when patients' health is getting worse in hospital wards. Patients with serious medical conditions, such as pneumonia or heart problems, will be monitored closely using wireless devices that send real-time alerts to healthcare staff if there are any concerning changes in their vital signs, like heart rate or blood pressure. The goal is to find out if this constant monitoring and alert system can reduce the time patients spend with dangerously abnormal vital signs compared to standard monitoring without alerts.

To participate, you must be an adult (18 years or older) who is admitted to the hospital with a serious medical issue and expected to stay overnight. You’ll need to show certain signs of being at high risk, like having trouble breathing or abnormal blood pressure. However, if you're in palliative care or have a device like a pacemaker, you won't be eligible. If you join the study, you can expect to be closely monitored, and your healthcare team will use the alerts to respond quickly if your condition changes. This trial is currently looking for participants, and it's an opportunity to contribute to improving patient care in hospitals.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion and randomization possible within 12 hours of fulfilling all other inclusion criteria below.
• • Adult patients (≥18 years).
• • At least one (additional) expected overnight stay.
• * High-risk medical admission, defines as EITHER:
• * one or more of the following symptoms or tentative diagnoses: Pneumonia, dyspnea, acute coronary syndrome, new onset heart failure or sepsis WITH two or more of the following deviations in vital signs recorded at one time point within 48 hours of admission:
• • Respiratory rate ≥ 21 min-1 or ≤ 7 min-1
• • Oxygen saturation of arterial hemoglobin ≤ 93 %
• • Pulse rate ≥ 111 min-1 or ≤ 40 min-1
• • Systolic blood pressure ≤ 100 mmHg or \> 200 mmHg
• • Temperature \> 39 °C or ≤ 35,9 °C
• • Any alteration in mental status
• • Any oxygen supplementation
• • OR
• • ○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission.
• Exclusion Criteria:
• • Patient expected not to cooperate with study procedures.
• • Allergy to plaster or silicone.
• • Patients admitted for palliative care only (i.e. no active treatment).
• • Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
• • Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
• • Patients previously enrolled in the surgical ward RCT
• • A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
• • Inability to give informed consent.