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

Sponsor
University Hospital Bispebjerg and Frederiksberg (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04305262
Collaborator
Technical University of Denmark (Other), Bispebjerg Hospital (Other), Rigshospitalet, Denmark (Other)
0
9.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wireless continuous vital parameter monitoring

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Mar 25, 2020
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Serious desaturation [more than 10 minutes, within the first four days of acute admission]

    SpO2 <85% in 10 consecutive minutes

Secondary Outcome Measures

  1. desaturation [more than 60 minutes, within the first four days of acute admission]

    SpO2 <92% in 60 consecutive minutes

  2. tachycardia [one minute within the first four days of admission]

    Heartrate >130/min

  3. bradycardia [one minute within the first four days of admission]

    heartrate >41/min

  4. tachypnea [one minute within the first four days of admission]

    Respiration rate >24/min

  5. bradypnea [one minute within the first four days of admission]

    Respiration rate <9/min

  6. hypotension [one measurement within the first four days of admission]

    Systolic blood pressure <90 mmHg

  7. hypertension [one measurement wihtin the first four days of admission]

    systolic blood pressure >219 mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital Bispebjerg and Frederiksberg
  • Technical University of Denmark
  • Bispebjerg Hospital
  • Rigshospitalet, Denmark

Investigators

  • Study Chair: Christian Meyhoff, MD, PhD, Bispebjerg Hospital
  • Principal Investigator: Katja Grønbæk, MD, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katja Kjær Grønbæk, MD, PhD-student, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier:
NCT04305262
Other Study ID Numbers:
  • H-19086056
First Posted:
Mar 12, 2020
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022