Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted t… (NCT04661748) | Clinical Trial Compass
CompletedNot Applicable
Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
Denmark300 participantsStarted 2022-01-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Timeframe: 5 days after inclusion or until discharge
2
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Timeframe: 5 days after inclusion or until discharge
3
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Timeframe: 5 days after inclusion or until discharge
4
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Timeframe: 5 days after inclusion or until discharge
5
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Timeframe: 5 days after inclusion or until discharge
6
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
Trial details
NCT IDNCT04661748
SponsorUniversity Hospital Bispebjerg and Frederiksberg