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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03461133
Other study ID # DrePaSiNet
Secondary ID
Status Completed
Phase N/A
First received February 25, 2018
Last updated March 4, 2018
Start date January 2015
Est. completion date February 2018

Study information

Verified date March 2018
Source University Hospital Carl Gustav Carus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3827
Est. completion date February 2018
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Admission to one of the participating wards

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Germany University Hospital Dresden Dresden

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Carl Gustav Carus

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

Müller 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary In hospital cardiac arrests Patient cardiac arrests during stay on average 14 days per patient, cumulative over 12 months in each observed cohort
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