Clinical trial NCT04055350: Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients
Official title: Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevention of In-hospital Adverse Events
Keywords: National early warning score
Prevention of serious adverse events
Patient deterioration
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult in-hospital patients in Pirkanmaa Hospital District whose vital signs have been recorded with mobile smart devices during the study period.

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.

Eligibility criteria: Inclusion Criteria:

* Adult in-hospital patients with recordings of vital signs

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Death occurring within 90-days of the last NEWS measurement
timeFrame: 90 days
measure: Death occurring within one day after the first NEWS measurement on general wards
timeFrame: One day
Secondary outcomes:
measure: Death occurring within 30-days of the last NEWS measurement
timeFrame: 30 days
measure: Death occurring within 2-30 days after the first NEWS measurement on general wards
timeFrame: 2-30 days
measure: Incidence of post operative nausea and vomiting
timeFrame: Up to 30 days after the first recording of patient's vital signs in the electronic patient records
measure: Incidence of post operative pain
timeFrame: Up to 30 days after the first recording of patient's vital signs in the electronic patient records
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
References:
citation: Loisa E, Kallonen A, Hoppu S, Tirkkonen J. Ability of the National Early Warning Score and its respiratory and haemodynamic subcomponents to predict short-term mortality on general wards: a prospective three-centre observational study in Finland. BMJ Open. 2022 Apr 26;12(4):e055752. doi: 10.1136/bmjopen-2021-055752.