Chronic Obstructive Pulmonary DiseaseWARD-COPDNCT03467815
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Dyspnea, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
For patients admitted to the medical ward, it is usually 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, Dyspnea
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2018to 7 Jun 2018
- 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: Adult patients admitted to hospital for Acute Exacerbation of COPD.
Who may be able to join
- Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.
Who cannot join
- Patient expected not to cooperate.
- Patient allergic to plaster, plastic or silicone.
- Active therapy withdrawn
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - A Pilot Study
For patients admitted to the medical ward, it is usually 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 progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.
- Conditions
- Chronic Obstructive Pulmonary Disease, Dyspnea
- Keywords
- Wireless monitoring, Continuous monitoring, Vital parameters, Clinical deterioration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Clinical Deterioration
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
Hypoxemia: arterial oxygen saturation < 92 %
Measured: The patients are monitored for 4 days
Heart rate resulting in a single parameter score of 3 according to EWS algorithm
All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used:
Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm
Measured: The patients are monitored for 4 days
Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm
Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min
Measured: The patients are monitored for 4 days
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg
Measured: The patients are monitored for 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start15 Mar 2018
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Mikkel Elvekjaer, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467815
- Sponsor's protocol ID
- Bispebjerg Hospital Research
- Acronym
- WARD-COPD
- Status last verified
- Aug 2018
- First submitted
- 12 Mar 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - A Pilot Study
- ClinicalTrials.gov ID
- NCT03467815
- Acronym / sponsor ID
- WARD-COPD / Bispebjerg Hospital Research
- Conditions
- Chronic Obstructive Pulmonary Disease, Dyspnea
- Keywords
- Wireless monitoring, Continuous monitoring, Vital parameters, Clinical deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Technical University of Denmark, Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 16 Mar 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 usually 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 progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.
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
- Adult patients admitted to hospital for Acute Exacerbation of COPD.
Key inclusion criteria (1 listed)
- Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.
Key exclusion criteria (3 listed)
- Patient expected not to cooperate.
- Patient allergic to plaster, plastic or silicone.
- Active therapy withdrawn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
Hypoxemia: arterial oxygen saturation < 92 %
Heart rate resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used: Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm
Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg
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 2018.
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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 Chronic Obstructive Pulmonary Disease and Dyspnea, run by Bispebjerg Hospital 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 1 inclusion and 3 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 2018. 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?
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm (time frame: The patients are monitored for 4 days). The study lists 4 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 27 Aug 2018.