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CompletedNCT03467815WARD-COPDUpdated Aug 27, 2018

Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease

An observational study in Chronic Obstructive Pulmonary Disease and Dyspnea, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by Bispebjerg Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Dyspnea

Keywords

  • Wireless monitoring
  • Continuous monitoring
  • Vital parameters
  • Clinical deterioration
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's enrollment of 30 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted to hospital for Acute Exacerbation of COPD.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adult patients admitted to hospital for Acute Exacerbation of (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.

Exclusion criteria

Exclusion Criteria:

  • Patient expected not to cooperate.
  • Patient allergic to plaster, plastic or silicone.
  • Active therapy withdrawn
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm

    Hypoxemia: arterial oxygen saturation \< 92 %

    Time frame: The patients are monitored for 4 days

  2. 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

    Time frame: The patients are monitored for 4 days

  3. Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm

    Bradypnea: \< 9 breaths/min Tachypnea: \> 24 breaths/min

    Time frame: The patients are monitored for 4 days

  4. 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

    Time frame: The patients are monitored for 4 days

07

Study locations

1 site
  • Bispebjerg Hospital
    Copenhagen, 2400, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Jun 2018, 2 months.

Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 2 months is below that.

Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 16, 2018
StartActual
Mar 15, 2018
Primary completionActual
Jun 7, 2018
CompletionActual
Jun 7, 2018
Last update
Aug 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03467815
Collaborators
Technical University of Denmark, Rigshospitalet, Denmark
Responsible party
Mikkel Elvekjaer (M.D., Bispebjerg Hospital) — Principal investigator
First posted
Mar 16, 2018
Start date
Mar 15, 2018
Primary completion
Jun 7, 2018
Completion
Jun 7, 2018
Last update
Aug 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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