Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients

• Conditions: Prevention of In-hospital Adverse Events

• Registration Number: NCT04055350
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Primary Completion: 2019-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-21
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

• Adult in-hospital patients with recordings of vital signs

Exclusion Criteria

• Patients under 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death occurring within one day after the first NEWS measurement on general wards	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	90 days	The percentage of patients that die within 90-days of the last NEWS recording during their hospitalization.

Secondary Outcome Measures

Name	Time	Method
Incidence of post operative pain	Up to 30 days after the first recording of patient's vital signs in the electronic patient records	Percentage of patients suffering from post operative pain (recorded as numerical scale from 0 to 10) 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	Percentage of patients suffering from post-operative nausea and vomiting (recorded as a scale from 0 to 5) in the electronic patient records.
Death occurring within 30-days of the last NEWS measurement	30 days	The percentage of patients that die within 30-days of the last NEWS recording during their hospitalization.
Death occurring within 2-30 days after the first NEWS measurement on general wards	2-30 days	The percentage of patients that die within 2-30 days after their first NEWS measurement at the beginning of their general ward admission

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland