Prevention of In-hospital Adverse EventsNCT04055350
Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients
An observational study of Prevention of In-hospital Adverse Events, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of In-hospital Adverse Events
- How many people
- 30,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2019to 30 Jun 2022
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult in-hospital patients in Pirkanmaa Hospital District whose vital signs have been recorded with mobile smart devices during the study period.
Who may be able to join
- Adult in-hospital patients with recordings of vital signs
Who cannot join
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.
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.
Read the 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.
- Conditions
- Prevention of In-hospital Adverse Events
- Keywords
- National early warning score, Prevention of serious adverse events, Patient deterioration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
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
Measured: One day
Secondary outcomes (4)
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.
Measured: 30 days
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
Measured: 2-30 days
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.
Measured: Up to 30 days after the first recording of patient's vital signs in the electronic patient records
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.
Measured: Up to 30 days after the first recording of patient's vital signs in the electronic patient records
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of In-hospital Adverse EventsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joonas Tirkkonen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055350
- Sponsor's protocol ID
- R20007R
- Status last verified
- Dec 2021
- First submitted
- 5 Aug 2019
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data security policies, individual participant data will not be shared.
Publications
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.
PubMed 35473725
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.
- ClinicalTrials.gov ID
- NCT04055350
- Acronym / sponsor ID
- R20007R
- Conditions
- Prevention of In-hospital Adverse Events
- Keywords
- National early warning score, Prevention of serious adverse events, Patient deterioration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult in-hospital patients in Pirkanmaa Hospital District whose vital signs have been recorded with mobile smart devices during the study period.
Key inclusion criteria (1 listed)
- Adult in-hospital patients with recordings of vital signs
Key exclusion criteria (1 listed)
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
4 secondary outcomes
Death occurring within 30-days of the last NEWS measurement
Time frame: 30 days
Death occurring within 2-30 days after the first NEWS measurement on general wards
Time frame: 2-30 days
Incidence of post operative nausea and vomiting
Time frame: Up to 30 days after the first recording of patient's vital signs in the electronic patient records
Incidence of post operative pain
Time frame: Up to 30 days after the first recording of patient's vital signs in the electronic patient records
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Derived from this study: PubMed 35473725Loisa 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.
- Individual participant dataSharing planned: No. Due to data security policies, individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of In-hospital Adverse Events, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death occurring within 90-days of the last NEWS measurement (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.