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Clinical Trials/NCT04248842
NCT04248842
Completed
Not Applicable

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

University Hospital Bispebjerg and Frederiksberg1 site in 1 country20 target enrollmentJanuary 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University Hospital Bispebjerg and Frederiksberg
Enrollment
20
Locations
1
Primary Endpoint
Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 23, 2020
End Date
June 4, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Responsible Party
Principal Investigator
Principal Investigator

Mikkel Elvekjaer

MD, Principal Investigator

University Hospital Bispebjerg and Frederiksberg

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

Outcomes

Primary Outcomes

Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)

Time Frame: 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)

Time Frame: 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 heart rate (beats per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue)

Time Frame: 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 observation

Time Frame: 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 three 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)

Time Frame: 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.

Study Sites (1)

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