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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04248842
Enrollment
20
Registered
2020-01-30
Start date
2020-01-23
Completion date
2020-06-04
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Continuous monitoring, Wireless monitoring

Brief 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. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 27/7 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. As part of the WARD-COPD project, this validation study aim to assess the accuracy of physiologic parameters derived from standard and wireless patient monitors

Interventions

Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor (Meditech Blue BP-05), Nonin WristOx 3150 as well as departments standard monitors

Sponsors

University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

\- Adult patients admitted with AECOPD

Exclusion criteria

* Patient expected not to cooperate * Patient allergic to plaster, plastic or silicone * Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit

Design outcomes

Primary

MeasureTime frameDescription
Comparison of heart rate (beats per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue)Two hours of monitoring (measurement interval of 15 mins)Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of respiratory rate (breaths per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue) vs direct observationTwo hours of monitoring (measurement interval of 15 mins)Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the three methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)Two hours of monitoring (measurement interval of 15 mins)Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of peripheral oxygen saturation (percent) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)Two hours of monitoring (measurement interval of 15 mins)Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of systolic and diastolic blood pressure (mmHg) measurement with Meditech BP-05 vs standard monitoring (Phillips IntelliVue)Two hours of monitoring (measurement interval of 15 mins)Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026