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

NCT ID: NCT04661748

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2024-12-31

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.

Detailed Description

Deterioration of patients on general hospital wards often goes unnoticed for prolonged periods of time. This delay can potentially result in severe adverse outcomes such as cardiopulmonary arrest and need for admission to the intensive care unit (ICU). These complications occur despite the fact that, in most cases, measurable changes in physiological vital signs, could identify patients at risk. Moreover, occurrence of complications increase treatment costs considerably underpinning the rationale of early detection of patient deterioration in both human and economic terms.

Monitoring of vital signs outside of ICU or telemetry units usually relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 hours with the "Early Warning Score (EWS)", "Tidlig Opsporing af Kritisk Sygdom (TOKS)" or similar systems. However, significant deterioration may occur in-between these intervals, which may explain the EWS/TOKS score's proven lack of impact on morbidity and mortality in Danish hospitals.

Recent medico-technical advances have allowed for clinical use of small wireless wear-and-forget devices that continuously monitor various indices of cardiopulmonary status, ambulatory activity, temperature etc. Studies suggest that integration of continuous monitoring into automated patient surveillance systems more often detects cardiorespiratory instability and may decrease number of Emergency Response Team activations, ICU transfers, length of hospital stay, morbidity and mortality but further randomized controlled trials (RCTs) are needed to confirm this. Other advantages may be a decrease in the time required for vital signs measurement and recording compared to routine monitoring and overall health care cost savings with return-on-investment estimates ranging from 127%-1739%.

Conditions

Alert Fatigue, Health Personnel; Deterioration, Clinical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

Active alarms

Group Type: ACTIVE_COMPARATOR

real time alarm of deviating vital signs

Intervention Type: DEVICE

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

no intervention

No alarms

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

real time alarm of deviating vital signs

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Katja Kjær Grønbæk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katja K Grønbæk, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg and Frederiksberg Hospital

København NV, Region H, Denmark

Countries

Denmark

Other Identifiers

H-20033246

Identifier Type: -

Identifier Source: org_study_id