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

Withdrawn

• Conditions: Continuous Wireless Vital Parameter Monitoring

• Registration Number: NCT04305262
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-12
• Study Start: 2020-03-25
• Primary Completion: 2020-08-01
• Study Completion: 2020-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious desaturation	more than 10 minutes, within the first four days of acute admission	SpO2 \<85% in 10 consecutive minutes

Secondary Outcome Measures

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