Automated Early Warning Scoring on Surgical Normal Wards

NCT ID: NCT03461133

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3827 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-02-28

Brief Summary

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Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care. Upon meeting of predefined trigger criteria Medical Emergency Teams (MET) should be directed to these patients. The present study analyses the effect of introduction of an automated early warning and trigger system on two peripheral wards hosting a highly complex surgical patient cohort.

Detailed Description

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The deployment of an electronic monitoring and notification system is accompanied by data acquisition over 12 months (intervention) using four routine databases: Hospital patient data management, anesthesia database, local data of the German Resuscitation Registry, and measurement logs of the automated patient monitoring and alert system (intervention period only). A preceding time period of 12 months served as control.

Conditions

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Safety Issues Emergencies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Reference

All patients admitted to the participating surgical wards from 2015-01-01 to 2015-12-31

No interventions assigned to this group

Intervention

All patients admitted to the participating surgical wards from 2016-07-01 to 2017-06-30

Intervention

Intervention Type OTHER

The emergency notification system is linked to a paging system to the surgeon in charge and to the Hospital Medical Emergency Team. Depending on individual Multiparameter Early Warning Score communication protocols are activated.

Interventions

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Intervention

The emergency notification system is linked to a paging system to the surgeon in charge and to the Hospital Medical Emergency Team. Depending on individual Multiparameter Early Warning Score communication protocols are activated.

Intervention Type OTHER

Other Intervention Names

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Automated early warning score and notification system

Eligibility Criteria

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Inclusion Criteria

* Admission to one of the participating wards

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Carl Gustav Carus

OTHER

Sponsor Role lead

Responsible Party

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Axel R. Heller

Head of Emergency Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Axel R. Heller, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Dresden, GERMANY

Locations

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University Hospital Dresden

Dresden, , Germany

Site Status

Countries

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Germany

References

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Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

Reference Type BACKGROUND
PMID: 22998715 (View on PubMed)

Ludikhuize J, Brunsveld-Reinders AH, Dijkgraaf MG, Smorenburg SM, de Rooij SE, Adams R, de Maaijer PF, Fikkers BG, Tangkau P, de Jonge E; Cost and Outcomes of Medical Emergency Teams Study Group. Outcomes Associated With the Nationwide Introduction of Rapid Response Systems in The Netherlands. Crit Care Med. 2015 Dec;43(12):2544-51. doi: 10.1097/CCM.0000000000001272.

Reference Type BACKGROUND
PMID: 26317569 (View on PubMed)

Muller MP, Richter T, Papkalla N, Poenicke C, Herkner C, Osmers A, Brenner S, Koch T, Schwanebeck U, Heller AR. Effects of a mandatory basic life support training programme on the no-flow fraction during in-hospital cardiac resuscitation: an observational study. Resuscitation. 2014 Jul;85(7):874-8. doi: 10.1016/j.resuscitation.2014.03.046. Epub 2014 Mar 28.

Reference Type BACKGROUND
PMID: 24686020 (View on PubMed)

Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.

Reference Type BACKGROUND
PMID: 28288655 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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DrePaSiNet

Identifier Type: -

Identifier Source: org_study_id

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