Clinical trial NCT04305262: Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Continuous Wireless Vital Parameter Monitoring
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Bispebjerg Hospital
name: Rigshospitalet, Denmark
First posted: 2020-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients at general medical wards, that are in high-risk of deterioration

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Serious desaturation
timeFrame: more than 10 minutes, within the first four days of acute admission
Secondary outcomes:
measure: desaturation
timeFrame: more than 60 minutes, within the first four days of acute admission
measure: tachycardia
timeFrame: one minute within the first four days of admission
measure: bradycardia
timeFrame: one minute within the first four days of admission
measure: tachypnea
timeFrame: one minute within the first four days of admission
measure: bradypnea
timeFrame: one minute within the first four days of admission
measure: hypotension
timeFrame: one measurement within the first four days of admission
measure: hypertension
timeFrame: one measurement wihtin the first four days of admission
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital
name: Christian Meyhoff, MD, PhD
role: STUDY_CHAIR
affiliation: Bispebjerg Hospital
name: Katja Grønbæk, MD
role: PRINCIPAL_INVESTIGATOR
References: