Vital SignsNCT05171322
Using Technical Filtering and Clinical Criteria to Reduce Vital Sign Alarms Using Continuous Monitoring in the Ward
An observational study of Vital Signs, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to describe the extent of vital sign threshold alarm reduction in relation to several simple multilevel minimum duration criteria and artefact removal. We hypothesize that the amount off false alarms will be decreased using different filters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Signs
- What is being tested?
- WARD
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 850 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2018to 15 Jan 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients are included from prospective WARD studies. The WARD surgery project (NCT03491137), the WARD COPD project (NCT03660501), the WARD CGM (NCT04473001), the WARD CODP pilot project (NCT03467815) and the WARD VASC project (NCT04628858).
Who may be able to join
- WARD COPD project (NCT03660501):
- ≥18 years
- Patients admitted to emergency departments or pulmonary wards with AECOPD as admission diagnosis with suspected acute exacerbation of COPD
- The diagnosis had to be sustained in the patient record at the time of inclusion
- Expected admittance longer than 24 hours
- Possibility of an investigator to include the patient within 24 hours from admission
Show all 20Show fewer
- The WARD surgery project (NCT03491137):
- ≥ 60 years
- Elective major abdominal cancer surgery
- Estimated surgical duration ≥ 2 hours.
- WARD VASC project (NCT04628858):
- ≥ 18 years
- Patients with PAD which must undergo an open intraligamentary revascularization incl. a. femoralis TEA and intraligamentary bypass
- Patients admitted at the department of vascular surgery 3111 at Rigshospitalet regarding elective surgery
- Patients admitted the day before surgery and have an expected admitting time lasting more than 2 days (postoperatively)
- WARD CGM (NCT04473001):
- Adult patients ≥ 18 years
- Patients admitted at Rigshospitalet or Bispebjerg hospital for major abdominal surgery or major orthopedic surgery or major arterial vascular surgery
- Estimated duration of surgery ≥ 1 hour and at least one expected overnight stay at the hospital postoperatively
- Type 1 diabetes or type 2 diabetes treated with insulin or type 2 diabetes treated with oral antihyperglycemic drugs/GLP-1 analogs or patients with no diabetes
Who cannot join
- WARD COPD project (NCT03660501):
- Patients who were not expected to cooperate to wear the monitoring equipment
- Unable to give informed consent
- Patients who were withheld active treatment
- Implanted cardioverter defibrillator or pacemaker
- Severe allergy for plaster/silicone
Show all 37Show fewer
- WARD CODP pilot project (NCT03467815):
- ≥ 18 years
- Patients admitted with AECOPD as admission diagnosis (this diagnosis had to be maintained in the patient record at time of inclusion)
- The WARD surgery project (NCT03491137):
- Implanted cardioverter defibrillator or pacemaker
- Allergy to study devices
- Severe cognitive impairment assessed by MMSE
- Inability to cooperate wearing the wireless monitoring equipment
- WARD CODP pilot project (NCT03467815):
- Unable to give informed consent
- Inability to cooperate to wear the monitoring equipment
- Active therapy withdrawn
- Expected duration of admission less than 24 hours after possible enrolment
- Allergies to plaster, plastic or silicone
- WARD VASC project (NCT04628858):
- Inability to cooperate wearing the wireless monitoring equipment
- Unable to give informed consent due to dementia or other reason.
- Severe allergy for plaster/silicone
- Implanted cardioverter defibrillator or pacemaker
- Patients not expected to be admitted for over 24 hours from possible inclusion time
- Isolated patients/patients with possible MRSA
- Patients who where withheld active treatment
- Patients formerly included in WARD surgery or WARD COPD studies
- Patients with a difference in systolic BP > 20 mmHg between their two arms
- WARD CGM (NCT04473001):
- Patients expected not to corporate with study procedures
- Patients allergic to plaster or silicone
- Patients with impaired cognitive function
- Patients with any treatment limitation
- Previous or currently scheduled for pancreatectomy
- Patients with pacemaker or ICD device
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Department of Anesthesiology, Centre for Cancer and Organ Diseases
Copenhagen, Copenhagen Ø, 2100
About this study
The purpose of this study is to describe the extent of vital sign threshold alarm reduction in relation to several simple multilevel minimum duration criteria and artefact removal. We hypothesize that the amount off false alarms will be decreased using different filters.
Read the detailed description
Introduction: Early identification of patients who are at risk of severe vital sign deterioration is essential in reducing mortality in critically ill patients. Abnormal physiology often precedes adverse outcomes like unexpected cardiac arrest, unexpected admission to intensive care units (ICU) and unexpected death among hospitalized patients.
The system, which is currently being used at Danish hospitals for monitoring patient's vital signs, is the EWS system (Early Warning Score) carried out primarily by nurses. The EWS monitors 7 parameters: Blood pressure (BP), heart rate (HR), blood saturation (SpO2), respiratory rate (RR), temperature, level of alertness and oxygen supplementation. Depending on the measured values, the EWS system determines the intervals with which nurses must measure vital signs. In case of aberrant signs medical staff is informed.
While simple continuous monitoring is rarely used outside the PACU or ICU, it presents the possibility of detecting early signs of deteriorations (ESODs), but has shown to induce alarm fatigue among hospital staff, thus increasing the risk of mortality. In addition the system is based on a "better-safe-than-sorry-logic", where a large amount of false alarms are accepted, rather than risking missing one correct alarm.
Aim: The aim of this study is to describe the extent of vital sign threshold alarm reduction in relation to several simple multilevel minimum duration criteria and artefact removal. We hypothesize that the amount off false alarms will be decreased using different filters.
Methods: The study is a prospective, descriptive cohort study, where patients were included from prospective WARD studies. Data will be analysed using different filters and a duration criteria. First data is analysed without artefact removal, where alarms are collected as in the ward, where alarms are activated if any vitals sign is below or above the threshold for a minimum of 15 seconds. Next data is filtered and analysed with artefact removal and finally data is filtered and analysed with a duration criteria. Furthermore, the available data are without staff interventions and may thus represent cases where the first alert would result in effective treatment and that subsequent alerts were averted. To assess this the data will be analysed for number of alerts if the first alert removed 100%, 75%, 50%, 25% and 0% of the following same alerts within the first hour, the following 3, 6, 12 and 24 hours.
Results: The primary analysis will be number of vital sign threshold alarms/patients/day for the alarms with artefact removal but without a duration criteria compared to the alarms with artefact removal and a duration criteria. The two filters will be compared using either a paired Student's t-test or a paired Mann-Whitney U test. The secondary and tertiary analysis of the secondary and tertiary outcomes will be performed using either a paired Student's t-test or a paired Mann-Whitney U test.
- Conditions
- Vital Signs
- Being tested
- WARD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARDDevice
The following monitoring devices are included in the WARD monitoring system (as intervention):
Isansys Life Touch patch: Measures heart rate (HR), respiratory rate (RR) and electrocardiogram (ECG)
Wearable, wireless Pulse Oximeter (Model 3150 WristOx from Nonin): Measures peripheral oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)
Blood pressure monitor (Meditech BlueBP-05): Measures BP every 30 minutes during daytime and every 60 minutes during the night
All included patients are set up with the monitoring devices after surgery when they are back at their ward (with a maximum of 24 hours postoperative). Afterwards they wear the devices for up to 5 days. All measurements are sent through bluetooth to a tablet serving as a gateway which in turn sends data to a central server where the algorithmic processing ensures.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients included were set up with the WARD monitoring devices. Receives: Device: WARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated number of any vital sign threshold alarms/patient/24 hours (bradypnea, tachypnea, desaturation, sinus tachycardia, bradycardia, hypotension and hypertension).
Measured: 24 hours
Secondary outcomes (7)
Number of bradypnea threshold alarms/patient/24 hours.
Measured: 24 hours
Number of tachypnea threshold alarms/patient/24 hours.
Measured: 24 hours
Number of desaturation threshold alarms/patient/24 hours.
Measured: 24 hours
Number of sinus tachycardia threshold alarms/patient/24 hours.
Measured: 24 hours
Number of bradycardia threshold alarms/patient/24 hours.
Measured: 24 hours
Number of hypotension threshold alarms/patient/24 hours.
Measured: 24 hours
Number of hypertension threshold alarms/patient/24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start20 Feb 2018
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 850 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karoline Kjærgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171322
- Sponsor's protocol ID
- AWARD (Alert WARD)
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technical Filtering and Clinical Criteria to Reduce Vital Sign Alarms Using Continuous Monitoring in the Ward
- ClinicalTrials.gov ID
- NCT05171322
- Acronym / sponsor ID
- AWARD (Alert WARD)
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the extent of vital sign threshold alarm reduction in relation to several simple multilevel minimum duration criteria and artefact removal. We hypothesize that the amount off false alarms will be decreased using different filters.
Detailed description
Introduction: Early identification of patients who are at risk of severe vital sign deterioration is essential in reducing mortality in critically ill patients. Abnormal physiology often precedes adverse outcomes like unexpected cardiac arrest, unexpected admission to intensive care units (ICU) and unexpected death among hospitalized patients.
The system, which is currently being used at Danish hospitals for monitoring patient's vital signs, is the EWS system (Early Warning Score) carried out primarily by nurses. The EWS monitors 7 parameters: Blood pressure (BP), heart rate (HR), blood saturation (SpO2), respiratory rate (RR), temperature, level of alertness and oxygen supplementation. Depending on the measured values, the EWS system determines the intervals with which nurses must measure vital signs. In case of aberrant signs medical staff is informed.
While simple continuous monitoring is rarely used outside the PACU or ICU, it presents the possibility of detecting early signs of deteriorations (ESODs), but has shown to induce alarm fatigue among hospital staff, thus increasing the risk of mortality. In addition the system is based on a "better-safe-than-sorry-logic", where a large amount of false alarms are accepted, rather than risking missing one correct alarm.
Aim: The aim of this study is to describe the extent of vital sign threshold alarm reduction in relation to several simple multilevel minimum duration criteria and artefact removal. We hypothesize that the amount off false alarms will be decreased using different filters.
Methods: The study is a prospective, descriptive cohort study, where patients were included from prospective WARD studies. Data will be analysed using different filters and a duration criteria. First data is analysed without artefact removal, where alarms are collected as in the ward, where alarms are activated if any vitals sign is below or above the threshold for a minimum of 15 seconds. Next data is filtered and analysed with artefact removal and finally data is filtered and analysed with a duration criteria. Furthermore, the available data are without staff interventions and may thus represent cases where the first alert would result in effective treatment and that subsequent alerts were averted. To assess this the data will be analysed for number of alerts if the first alert removed 100%, 75%, 50%, 25% and 0% of the following same alerts within the first hour, the following 3, 6, 12 and 24 hours.
Results: The primary analysis will be number of vital sign threshold alarms/patients/day for the alarms with artefact removal but without a duration criteria compared to the alarms with artefact removal and a duration criteria. The two filters will be compared using either a paired Student's t-test or a paired Mann-Whitney U test. The secondary and tertiary analysis of the secondary and tertiary outcomes will be performed using either a paired Student's t-test or a paired Mann-Whitney U test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: WARDAll patients included were set up with the WARD monitoring devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients are included from prospective WARD studies. The WARD surgery project (NCT03491137), the WARD COPD project (NCT03660501), the WARD CGM (NCT04473001), the WARD CODP pilot project (NCT03467815) and the WARD VASC project (NCT04628858).
Key inclusion criteria (20 listed)
- ≥18 years
- Patients admitted to emergency departments or pulmonary wards with AECOPD as admission diagnosis with suspected acute exacerbation of COPD
- The diagnosis had to be sustained in the patient record at the time of inclusion
- Expected admittance longer than 24 hours
- Possibility of an investigator to include the patient within 24 hours from admission
Key exclusion criteria (37 listed)
- Patients who were not expected to cooperate to wear the monitoring equipment
- Unable to give informed consent
- Patients who were withheld active treatment
- Implanted cardioverter defibrillator or pacemaker
- Severe allergy for plaster/silicone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WARDThe following monitoring devices are included in the WARD monitoring system (as intervention): Isansys Life Touch patch: Measures heart rate (HR), respiratory rate (RR) and electrocardiogram (ECG) Wearable, wireless Pulse Oximeter (Model 3150 WristOx from Nonin): Measures peripheral oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) Blood pressure monitor (Meditech BlueBP-05): Measures BP every 30 minutes during daytime and every 60 minutes during the night All included patients are set up with the monitoring devices after surgery when they are back at their ward (with a maximum of 24 hours postoperative). Afterwards they wear the devices for up to 5 days. All measurements are sent through bluetooth to a tablet serving as a gateway which in turn sends data to a central server where the algorithmic processing ensures. | Device | All patients |
Primary outcome
Calculated number of any vital sign threshold alarms/patient/24 hours (bradypnea, tachypnea, desaturation, sinus tachycardia, bradycardia, hypotension and hypertension).
Time frame: 24 hours
7 secondary outcomes
Number of bradypnea threshold alarms/patient/24 hours.
Time frame: 24 hours
Number of tachypnea threshold alarms/patient/24 hours.
Time frame: 24 hours
Number of desaturation threshold alarms/patient/24 hours.
Time frame: 24 hours
Number of sinus tachycardia threshold alarms/patient/24 hours.
Time frame: 24 hours
Number of bradycardia threshold alarms/patient/24 hours.
Time frame: 24 hours
Number of hypotension threshold alarms/patient/24 hours.
Time frame: 24 hours
Number of hypertension threshold alarms/patient/24 hours.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculated number of any vital sign threshold alarms/patient/24 hours (bradypnea, tachypnea, desaturation, sinus tachycardia, bradycardia, hypotension and hypertension). (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.