Surgical ComplicationNCT05378139
Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
An observational study of Surgical Complication and Pulmonary Disease, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on: The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Complication, Pulmonary Disease, Hematologic Diseases
- What is being tested?
- Vital signs measurements with new app
- Type of treatment
- Medical device
- How many people
- 3,095 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 22 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia
Who may be able to join
- Adult participants (≥18 years)
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR
- Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia
Who cannot join
- The participant expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Having pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Aslak B Johansen, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Copenhagen, 2100
Eske Aasvang, MD, 26232076, eske.kvanner.aasvang@regionh.dk
About this study
Official title: WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on:
The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).
Read the detailed description
Over the last years, the applicants and research team partners have developed the WARD (Wireless Assessment of Respiratory and circulatory Distress) project, using continuous wireless monitoring of vital signs and artificial intelligence algorithms for data interpretation in high-risk patient admitted to medical and surgical wards. The WARD project combines continuous measurements of 10 different physiological modalities with machine learning to develop the WARD-Clinical Support System (WARD-CSS), based on multiple intelligent algorithms, that automatically monitors, interprets, predicts and alert clinical staff. Through a mobile device with a purpose-built Graphic User Interface (GUI), the WARD-CSS stimulates human-machine interaction to improve the monitoring of high-risk hospitalized patients.
The WARD project has hitherto proven an unmet need for continuous monitoring and the potential for automatic detection and prediction of physiological deterioration events. Specifically, observational pilot studies of both patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) and postoperative abdominal cancer surgery patients have shown that episodes of desaturation, tachycardia, tachypnea, and bradypnea are much more frequently detected using continuous vital signs monitoring than with existing Early Warning Score (EWS) systems.
Ongoing investigations will determine the efficacy in two very selected populations of high-risk surgical patients and acutely ill medical patients with severe disease. This study will investigate the WARD-systems' implementation, and effectiveness of use and impact in a cohort of patientparticipants admitted
- Conditions
- Surgical Complication, Pulmonary Disease, Hematologic Diseases, Oncology, Cardiac Disease, Infections
- Being tested
- Vital signs measurements with new app
- Medical subject headings
- Lung Diseases, Hematologic Diseases, Neoplasms, Heart Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital signs measurements with new appDevice
Patients vital signs are monitored through an app for the nurses to use
What is being measured
The primary outcome is the main question the study is designed to answer.
Data quality
The number (frequency) of patients having adequate data quality (defined as at least 60% of the monitoring time with simultaneous recording of SpO2, respiratory rate, heart rate)
Measured: 30 days
user satisfaction
Number of users with adequate clinical user satisfaction (defined as the nurse in charge of the patient at the end of monitoring answers "Agree" or "Strongly agree" to the question "WARD-monitoring was beneficial for monitoring of vital signs in this patientparticipant (response options: Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree)).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Feb 2021
- Primary completion27 Jun 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ComplicationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,095 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Katja Kjær Grønbæk, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378139
- Sponsor's protocol ID
- 2203648
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be decided upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization
- ClinicalTrials.gov ID
- NCT05378139
- Acronym / sponsor ID
- 2203648
- Conditions
- Surgical Complication, Pulmonary Disease, Hematologic Diseases, Oncology, Cardiac Disease, Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,095 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 27 Jun 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 18 May 2022 (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 primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on:
The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).
Detailed description
Over the last years, the applicants and research team partners have developed the WARD (Wireless Assessment of Respiratory and circulatory Distress) project, using continuous wireless monitoring of vital signs and artificial intelligence algorithms for data interpretation in high-risk patient admitted to medical and surgical wards. The WARD project combines continuous measurements of 10 different physiological modalities with machine learning to develop the WARD-Clinical Support System (WARD-CSS), based on multiple intelligent algorithms, that automatically monitors, interprets, predicts and alert clinical staff. Through a mobile device with a purpose-built Graphic User Interface (GUI), the WARD-CSS stimulates human-machine interaction to improve the monitoring of high-risk hospitalized patients.
The WARD project has hitherto proven an unmet need for continuous monitoring and the potential for automatic detection and prediction of physiological deterioration events. Specifically, observational pilot studies of both patients with acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) and postoperative abdominal cancer surgery patients have shown that episodes of desaturation, tachycardia, tachypnea, and bradypnea are much more frequently detected using continuous vital signs monitoring than with existing Early Warning Score (EWS) systems.
Ongoing investigations will determine the efficacy in two very selected populations of high-risk surgical patients and acutely ill medical patients with severe disease. This study will investigate the WARD-systems' implementation, and effectiveness of use and impact in a cohort of patientparticipants admitted
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia
Key inclusion criteria (3 listed)
- Adult participants (≥18 years)
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR
- Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia
Key exclusion criteria (4 listed)
- The participant expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Having pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- Inability to give informed consent.
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 |
|---|---|---|
| Vital signs measurements with new appPatients vital signs are monitored through an app for the nurses to use | Device | – |
Primary outcome
Data quality
Time frame: 30 days
The number (frequency) of patients having adequate data quality (defined as at least 60% of the monitoring time with simultaneous recording of SpO2, respiratory rate, heart rate)
user satisfaction
Time frame: 30 days
Number of users with adequate clinical user satisfaction (defined as the nurse in charge of the patient at the end of monitoring answers "Agree" or "Strongly agree" to the question "WARD-monitoring was beneficial for monitoring of vital signs in this patientparticipant (response options: Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree)).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided. Will be decided upon reasonable request
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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.
Aslak B Johansen, MD contact
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 Surgical Complication and Pulmonary Disease, run by University Hospital Bispebjerg and Frederiksberg 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eske Aasvang, MD (26232076, eske.kvanner.aasvang@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data quality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 11 Apr 2025.