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Clinical Trials/NCT04055350
NCT04055350
Unknown
Not Applicable

Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.

Tampere University Hospital1 site in 1 country30,000 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prevention of In-hospital Adverse Events
Sponsor
Tampere University Hospital
Enrollment
30000
Locations
1
Primary Endpoint
Death occurring within one day after the first NEWS measurement on general wards
Last Updated
4 years ago

Overview

Brief Summary

National early warning score (NEWS) enables early detection of patient deterioration in hospital floors. However, there is limited data on the prognostic value of NEWS among actual general ward patients. Further, there is no data on how changes in NEWS-values impact patient outcomes. Very little is known on how post-operative nausea and vomiting (PONV) and pain influences NEWS values and vital signs in general.

Detailed Description

The investigators aim to collect detailed data on patients' vital signs, NEWSs, pain scores and PONV scores through electronic data records, where these values are automatically stored with mobile mobile smart devices used by nursing staff. The expected volume of the cohort is 50,000 patients and 300,000 recordings of vital signs. In addition to the scores and vital signs, the registry will include patients' identification numbers (IDs), dates and times of the recordings, and ward numbers. With the IDs, mortality data up to 90-days for the patients will be obtained from the national population register centre. All data will be handled in a pseudonymized form in a secure computer inside hospital, and approval to use the registry in study purposes will be obtained from the Ethics Committee of Tampere University Hospital.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joonas Tirkkonen

MD, PhD. Resident in Anaesthesiology and Intensive Care Medicine. Principal Investigator in this Study.

Tampere University Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult in-hospital patients with recordings of vital signs

Exclusion Criteria

  • Patients under 18 years

Outcomes

Primary Outcomes

Death occurring within one day after the first NEWS measurement on general wards

Time Frame: One day

The percentage of patients that die within one day after their first NEWS measurement at the beginning of their general ward admission

Death occurring within 90-days of the last NEWS measurement

Time Frame: 90 days

The percentage of patients that die within 90-days of the last NEWS recording during their hospitalization.

Secondary Outcomes

  • Incidence of post operative pain(Up to 30 days after the first recording of patient's vital signs in the electronic patient records)
  • Incidence of post operative nausea and vomiting(Up to 30 days after the first recording of patient's vital signs in the electronic patient records)
  • Death occurring within 30-days of the last NEWS measurement(30 days)
  • Death occurring within 2-30 days after the first NEWS measurement on general wards(2-30 days)

Study Sites (1)

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