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

NCT ID: NCT04248842

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-23

Study Completion Date

2020-06-04

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Continuous monitoring system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role lead

Responsible Party

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Mikkel Elvekjaer

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Meyhoff, MD, PHD

Role: STUDY_CHAIR

Bispebjerg and Frederiksberg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33984846 (View on PubMed)

Other Identifiers

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WARD-COPD_validation

Identifier Type: -

Identifier Source: org_study_id

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