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

Prevention of In-hospital Adverse Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04055350
• Other study ID #: R20007R
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult in-hospital patients with recordings of vital signs

Exclusion Criteria:

• Patients under 18 years

Related Conditions & MeSH terms

• Prevention of In-hospital Adverse Events

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death occurring within 90-days of the last NEWS measurement	The percentage of patients that die within 90-days of the last NEWS recording during their hospitalization.	90 days
Primary	Death occurring within one day after the first NEWS measurement on general wards	The percentage of patients that die within one day after their first NEWS measurement at the beginning of their general ward admission	One day
Secondary	Death occurring within 30-days of the last NEWS measurement	The percentage of patients that die within 30-days of the last NEWS recording during their hospitalization.	30 days
Secondary	Death occurring within 2-30 days after the first NEWS measurement on general wards	The percentage of patients that die within 2-30 days after their first NEWS measurement at the beginning of their general ward admission	2-30 days
Secondary	Incidence of post operative nausea and vomiting	Percentage of patients suffering from post-operative nausea and vomiting (recorded as a scale from 0 to 5) in the electronic patient records.	Up to 30 days after the first recording of patient's vital signs in the electronic patient records
Secondary	Incidence of post operative pain	Percentage of patients suffering from post operative pain (recorded as numerical scale from 0 to 10) in the electronic patient records.	Up to 30 days after the first recording of patient's vital signs in the electronic patient records