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

NCT04661748 | Completed DMC

• 1 other identifier: H-20033246
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical conditions. Patients admitted with medical conditions represents a large and heterogenous group occupying a substantial part of the total in-patient capacity in the Danish hospitals today. The hypothesize is that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.

Conditions

Alert Fatigue, Health Personnel; Deterioration, Clinical

Outcome Measures

Primary Outcomes (6)

• Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:

  ● SpO2 \< 85%

  5 days after inclusion or until discharge

• Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:

  * Respiratory rate ≤ 5 min-1 * Respiratory rate \> 24 min-1

  5 days after inclusion or until discharge

• Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:

  * Heart rate \> 130 min-1 * Heart rate ≤ 30 min-1

  5 days after inclusion or until discharge

• Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:

  * Systolic blood pressure ≤ 90 mmHg * Systolic blood pressure \> 220 mmHg

  5 days after inclusion or until discharge

• Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:

  ● Atrial fibrillation

  5 days after inclusion or until discharge

• Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:

  ● Circulatory failure * Systolic blood pressure \< 100 mmHg AND * Heart rate \>110 min-1 (for more than 30 minutes) OR heart rate \>130 min-1 (for more than 5 minutes) OR heart rate \< 50 (for more than 30 minutes) AND/

  5 days after inclusion or until discharge

Secondary Outcomes (1)

• Frequency and duration of deviations in vital signs

  5 days after inclusion or until discharge

Other Outcomes (4)

• Number of patients with any adverse clinical outcomes

  30 days after inclusion

• Length of hospital stay (LOS)

  6 months after inclusion

• Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses

  2 years

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Active alarms

Device: real time alarm of deviating vital signs

no intervention

NO INTERVENTION

No alarms

Interventions

real time alarm of deviating vital signs DEVICE

Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Bispebjerg and Frederiksberg Hospital

København NV, Region H, 2400, Denmark

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel; Clinical Deterioration

Condition Hierarchy (Ancestors)

Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Disease Progression; Disease Attributes; Pathologic Processes

Study Officials

• Katja K Grønbæk, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 10, 2020
• Study Start: January 7, 2022
• Primary Completion: December 23, 2023
• Study Completion: December 31, 2024
• Last Updated: April 11, 2025

Record last verified: 2023-05

Locations

DK (1)