Continuous Wireless Vital Parameter Monitoring Clinical Trial
— WARDOfficial 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
| NCT number | NCT04305262 |
| Other study ID # | H-19086056 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 25, 2020 |
| Est. completion date | December 31, 2020 |
| Verified date | January 2022 |
| Source | University Hospital Bispebjerg and Frederiksberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | August 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Bispebjerg and Frederiksberg | Bispebjerg Hospital, Rigshospitalet, Denmark, Technical University of Denmark |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serious desaturation | SpO2 <85% in 10 consecutive minutes | more than 10 minutes, within the first four days of acute admission | |
| Secondary | desaturation | SpO2 <92% in 60 consecutive minutes | more than 60 minutes, within the first four days of acute admission | |
| Secondary | tachycardia | Heartrate >130/min | one minute within the first four days of admission | |
| Secondary | bradycardia | heartrate >41/min | one minute within the first four days of admission | |
| Secondary | tachypnea | Respiration rate >24/min | one minute within the first four days of admission | |
| Secondary | bradypnea | Respiration rate <9/min | one minute within the first four days of admission | |
| Secondary | hypotension | Systolic blood pressure <90 mmHg | one measurement within the first four days of admission | |
| Secondary | hypertension | systolic blood pressure >219 mmHg | one measurement wihtin the first four days of admission |