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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Dyspnea

• Registration Number: NCT03467815
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

For patients admitted to the medical ward, it is usually 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 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the number and duration of cardiopulmonary micro events during the first 4 days after hospital admission with Acute Exacerbation of COPD. We will also test the server installation, develop a database of core data and assess the frequency of artefacts and failure to capture the continuous monitoring signal.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study Start: 2018-03-15
• Study First Posted: 2018-03-16
• Primary Completion: 2018-06-07
• Study Completion: 2018-06-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adult patients admitted to hospital for Acute Exacerbation of COPD (AECOPD). Investigators will review the electronic patient chart for a primary diagnosis of AECOPD.

Exclusion Criteria

• Patient expected not to cooperate.
• Patient allergic to plaster, plastic or silicone.
• Active therapy withdrawn

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	Hypoxemia: arterial oxygen saturation \< 92 %
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	Hypotension: Systolic blood pressure \< 91 mmHg Hypertension: Systolic blood pressure \> 219 mmHg
Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	Bradypnea: \< 9 breaths/min Tachypnea: \> 24 breaths/min
Heart rate resulting in a single parameter score of 3 according to EWS algorithm	The patients are monitored for 4 days	All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used: Bradycardia: pulse \< 41 bpm Tachycardia: pulse \> 130 bpm

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark