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CompletedNCT03461133Updated Mar 9, 2018

Automated Early Warning Scoring on Surgical Normal Wards

An observational study in Safety Issues and Emergencies, sponsored by University Hospital Carl Gustav Carus. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2018-03-09.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by University Hospital Carl Gustav Carus · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,827
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Safety Issues
  • Emergencies

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03

In context

Lead sponsor

University Hospital Carl Gustav Carus is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

General surgery, vascular surgery, thoracic surgery,

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admission to one of the participating wards

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,827 participants (actual)
Patient registry
No

Groups and cohorts

  • Reference

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

  • Intervention

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

    Other: Intervention

Interventions

  • OtherIntervention

    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.

    Also known as: Automated early warning score and notification system

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What researchers measure

Primary outcomes

  1. In hospital cardiac arrests

    Patient cardiac arrests during stay

    Time frame: on average 14 days per patient, cumulative over 12 months in each observed cohort

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Study locations

1 site
  • University Hospital Dresden
    Dresden, D-01307, Germany
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References and documents

Publications

  • 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. PubMed 22998715 ↗
  • 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. PubMed 26317569 ↗
  • 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. PubMed 24686020 ↗
  • 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. PubMed 28288655 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — No individual participant data will be shared

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03461133
Lead sponsor
University Hospital Carl Gustav Carus
Responsible party
Axel R. Heller (Head of Emergency Services, University Hospital Carl Gustav Carus) — Principal investigator
First posted
Mar 9, 2018
Start date
Jan 2015
Primary completion
Jun 2017
Completion
Feb 2018
Last update
Mar 9, 2018

Study contacts

Axel R. Heller, MD
principal investigator · University Hospital Dresden, GERMANY

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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