Chronic Obstructive Pulmonary DiseaseWARD-COPDNCT03660501
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - an Observational Study
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
Trial summary
For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Continuous monitoring system
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- 12 Sep 2018to 21 Jun 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients admitted to hospital with acute exacerbation of COPD will be included in the study upon arrival to the medical ward.
Who may be able to join
- Adult patients admitted with AECOPD
- Recruitment and monitoring start is possible within 24 hours after admission
Who cannot join
- Patient expected not to cooperate
- Patient allergic to plaster, plastic or silicone
- Active therapy withdrawn
- Patients with dementia or not able to give informed consent
- Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
- Expected discharge within less than 24 hours from possible inclusion
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg Hospital
Copenhagen, 2400
Gentofte Hospital
Hellerup, 2900
About this study
Official title: Continuous Vital Sign Monitoring During Admission for Acute Exacerbations of Chronic Obstructive Pulmonary Disease - an Observational Study
For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission with acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Continuous monitoring system
- Keywords
- Continuous monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous monitoring systemDevice
Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor, Nonin WristOx 3150, Empatica E4, and Radiometer TCM5 FLEX monitor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Any serious adverse events
E.g. cardiac arrest, ICU admission, acute myocardial infarction, stroke, sepsis, acute kidney injury or other serious adverse events (defined in Protocol Appendix A)
Measured: within 30 days after inclusion
Secondary outcomes (2)
Mortality
Measured: within 6 months after inclusion
Readmission
Measured: within 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start12 Sep 2018
- Primary completion21 Dec 2019
- Study completion21 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Mikkel Elvekjaer, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian Meyhoff, MD, PHD, Study chair, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660501
- Sponsor's protocol ID
- WARD-COPD_v1.1
- Acronym
- WARD-COPD
- Status last verified
- Aug 2020
- First submitted
- 4 Sep 2018
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elvekjaer M, Rasmussen SM, Gronbaek KK, Porsbjerg CM, Jensen JU, Haahr-Raunkjaer C, Molgaard J, Sogaard M, Sorensen HBD, Aasvang EK, Meyhoff CS. Clinical impact of vital sign abnormalities in patients admitted with acute exacerbation of chronic obstructive pulmonary disease: an observational study using continuous wireless monitoring. Intern Emerg Med. 2022 Sep;17(6):1689-1698. doi: 10.1007/s11739-022-02988-w. Epub 2022 May 20.
PubMed 35593967
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Vital Sign Monitoring During Admission for Acute Exacerbations of Chronic Obstructive Pulmonary Disease - an Observational Study
- ClinicalTrials.gov ID
- NCT03660501
- Acronym / sponsor ID
- WARD-COPD / WARD-COPD_v1.1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Continuous monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Technical University of Denmark, Herlev and Gentofte Hospital
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 6 Sep 2018 (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.
For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission with acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients admitted to hospital with acute exacerbation of COPD will be included in the study upon arrival to the medical ward.
Key inclusion criteria (2 listed)
- Adult patients admitted with AECOPD
- Recruitment and monitoring start is possible within 24 hours after admission
Key exclusion criteria (6 listed)
- Patient expected not to cooperate
- Patient allergic to plaster, plastic or silicone
- Active therapy withdrawn
- Patients with dementia or not able to give informed consent
- Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
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 |
|---|---|---|
| Continuous monitoring systemPatients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor, Nonin WristOx 3150, Empatica E4, and Radiometer TCM5 FLEX monitor. | Device | – |
Primary outcome
Any serious adverse events
Time frame: within 30 days after inclusion
E.g. cardiac arrest, ICU admission, acute myocardial infarction, stroke, sepsis, acute kidney injury or other serious adverse events (defined in Protocol Appendix A)
2 secondary outcomes
Mortality
Time frame: within 6 months after inclusion
Readmission
Time frame: within 6 months after inclusion
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 27 Aug 2020.
- Derived from this study: PubMed 35593967Elvekjaer M, Rasmussen SM, Gronbaek KK, Porsbjerg CM, Jensen JU, Haahr-Raunkjaer C, Molgaard J, Sogaard M, Sorensen HBD, Aasvang EK, Meyhoff CS. Clinical impact of vital sign abnormalities in patients admitted with acute exacerbation of chronic obstructive pulmonary disease: an observational study using continuous wireless monitoring. Intern Emerg Med. 2022 Sep;17(6):1689-1698. doi: 10.1007/s11739-022-02988-w. Epub 2022 May 20.
- Individual participant dataSharing planned: No
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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.
Christian Meyhoff, MD, PHD study chair
Bispebjerg and Frederiksberg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital Bispebjerg and Frederiksberg at 2 sites 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 2 inclusion and 6 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Any serious adverse events (time frame: within 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03660501, which also lists 1 linked publication.
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 27 Aug 2020.