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

Chronic Obstructive Pulmonary Disease Clinical Trial

— WARD-COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467815
• Other study ID #: Bispebjerg Hospital Research
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: June 7, 2018

Study information

• Verified date: August 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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• Active therapy withdrawn

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Rigshospitalet, Denmark, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm	Hypoxemia: arterial oxygen saturation < 92 %	The patients are monitored for 4 days
Primary	Heart rate resulting in a single parameter score of 3 according to EWS algorithm	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	The patients are monitored for 4 days
Primary	Respiratory rate resulting in a single parameter score of 3 according to EWS algorithm	Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min	The patients are monitored for 4 days
Primary	Blood pressure resulting in a single parameter score of 3 according to EWS algorithm	Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg	The patients are monitored for 4 days