Clinical trial NCT04248842: Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study
Official title: Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Continuous monitoring
Wireless monitoring
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to hospital with acute exacerbation of COPD will be included in the study upon arrival to the medical ward.

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


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of heart rate (beats per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue)
timeFrame: Two hours of monitoring (measurement interval of 15 mins)
measure: Comparison of respiratory rate (breaths per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue) vs direct observation
timeFrame: Two hours of monitoring (measurement interval of 15 mins)
measure: Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)
timeFrame: Two hours of monitoring (measurement interval of 15 mins)
measure: Comparison of peripheral oxygen saturation (percent) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)
timeFrame: Two hours of monitoring (measurement interval of 15 mins)
measure: Comparison of systolic and diastolic blood pressure (mmHg) measurement with Meditech BP-05 vs standard monitoring (Phillips IntelliVue)
timeFrame: Two hours of monitoring (measurement interval of 15 mins)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital
name: Christian Meyhoff, MD, PHD
role: STUDY_CHAIR
References:
citation: Elvekjaer M, Carlsson CJ, Rasmussen SM, Porsbjerg CM, Gronbaek KK, Haahr-Raunkjaer C, Sorensen HBD, Aasvang EK, Meyhoff CS. Agreement between wireless and standard measurements of vital signs in acute exacerbation of chronic obstructive pulmonary disease: a clinical validation study. Physiol Meas. 2021 Jun 17;42(5). doi: 10.1088/1361-6579/ac010c.