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

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ClinicalTrials.gov Identifier: NCT04055350
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Joonas Tirkkonen, 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.

Condition or disease
Prevention of In-hospital Adverse Events

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, 90-day mortality of 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Death occurring within 30-days of the last NEWS measurement [ Time Frame: 30 days ]
    The percentage of patients that die within 30-days of the last NEWS recording during their hospitalization.

  2. 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 ]
    Percentage of patients suffering from post-operative nausea and vomiting (recorded as a scale from 0 to 5) in the electronic patient records.

  3. 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 ]
    Percentage of patients suffering from post operative pain (recorded as numerical scale from 0 to 10) in the electronic patient records.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Adult in-hospital patients with recordings of vital signs

Exclusion Criteria:

  • Patients under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055350


Contacts
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Contact: Joonas Tirkkonen, MD, PhD +3583311611 joonas.tirkkonen@pshp.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Pirkanmaa, Finland, 33520
Contact: Joonas Tirkkonen, MD, PhD    +3583311611    joonas.tirkkonen@pshp.fi   
Sub-Investigator: Sanna Hoppu, MD, PhD         
Sub-Investigator: Eetu Loisa, MD         
Sub-Investigator: Maija-Liisa Kalliomäki, MD, PhD         
Sponsors and Collaborators
Tampere University Hospital

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Responsible Party: Joonas Tirkkonen, MD, PhD. Resident in Anaesthesiology and Intensive Care Medicine. Principal Investigator in this Study., Tampere University Hospital
ClinicalTrials.gov Identifier: NCT04055350     History of Changes
Other Study ID Numbers: NEWSPONVPAINTAYS
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to data security policies, individual participant data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joonas Tirkkonen, Tampere University Hospital:
National early warning score
Prevention of serious adverse events
Patient deterioration