Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients (WARD)

Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients - a Part of the Wireless Assessment of Respiratory and Circulatory Distress (WARD) Project

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 24/7 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. The WARD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission.

Study Overview

• Status: Withdrawn
• Conditions: Continuous Wireless Vital Parameter Monitoring
• Intervention / Treatment: Device: Wireless continuous vital parameter monitoring

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients at general medical wards, that are in high-risk of deterioration

Description

Inclusion Criteria:

• Adults >18 years
• Acute hospitalization or discharge from Intensive Care Unit (ICU) after an admission of at least 24 hours.
• Early Warning Score (EWS) ≥4 at least once from admission and until inclusion
• One of the following tentative diagnoses as the primary reason for admission: Pneumonia, Dyspnea, Acute myocardial infarction, heartfailure or sepsis
• Inclusion conversation possible within 12 hours of admission or discharge from ICU

Exclusion Criteria:

• Patients that cannot cooperate
• Patients that cannot give informed consent
• Patients with EWS≥4 that is not of presumed physical origin
• Patients with allergies to plaster or silicone
• Patients with pacemaker or ICD
• Patients with treatment limitations (no resuscitation or no admission to ICU)
• Patients with expected discharge within 24 hours
• Patients that have been included in the WARD-COPD study (H-18026653)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious desaturation	SpO2 <85% in 10 consecutive minutes	more than 10 minutes, within the first four days of acute admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
desaturation	SpO2 <92% in 60 consecutive minutes	more than 60 minutes, within the first four days of acute admission
tachycardia	Heartrate >130/min	one minute within the first four days of admission
bradycardia	heartrate >41/min	one minute within the first four days of admission
tachypnea	Respiration rate >24/min	one minute within the first four days of admission
bradypnea	Respiration rate <9/min	one minute within the first four days of admission
hypotension	Systolic blood pressure <90 mmHg	one measurement within the first four days of admission
hypertension	systolic blood pressure >219 mmHg	one measurement wihtin the first four days of admission

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Rigshospitalet, Denmark; Bispebjerg Hospital; Technical University of Denmark
• Investigators: Study Chair: Christian Meyhoff, MD, PhD, Bispebjerg Hospital; Principal Investigator: Katja Grønbæk, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 25, 2020
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (ACTUAL): March 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: H-19086056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No