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

NCT04248842 | Completed

• 1 other identifier: WARD-COPD_validation
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Continuous monitoring; Wireless monitoring

Outcome Measures

Primary Outcomes (5)

• Comparison of heart rate (beats per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue)

  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.

  Two hours of monitoring (measurement interval of 15 mins)

• Comparison of respiratory rate (breaths per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue) vs direct observation

  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.

  Two hours of monitoring (measurement interval of 15 mins)

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

  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.

  Two hours of monitoring (measurement interval of 15 mins)

• Comparison of peripheral oxygen saturation (percent) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)

  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.

  Two hours of monitoring (measurement interval of 15 mins)

• Comparison of systolic and diastolic blood pressure (mmHg) measurement with Meditech BP-05 vs standard monitoring (Phillips IntelliVue)

  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.

  Two hours of monitoring (measurement interval of 15 mins)

Interventions

Continuous monitoring system DEVICE

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Adult patients admitted with AECOPD

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33984846 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Meyhoff, MD, PHD

  Bispebjerg and Frederiksberg Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 30, 2020
• Study Start: January 23, 2020
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)