Safety IssuesNCT03461133
Automated Early Warning Scoring on Surgical Normal Wards
An observational study of Safety Issues and Emergencies, run by University Hospital Carl Gustav Carus at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety Issues, Emergencies
- What is being tested?
- Intervention
- How many people
- 3,827 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General surgery, vascular surgery, thoracic surgery,
Who may be able to join
- Admission to one of the participating wards
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Deteriorating Patients on Peripheral Surgical Wards by an Automated Notification System
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.
- Conditions
- Safety Issues, Emergencies
- Being tested
- Intervention
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Automated early warning score and notification system
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital cardiac arrests
Patient cardiac arrests during stay
Measured: on average 14 days per patient, cumulative over 12 months in each observed cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study startJan 2015
- Primary completionJun 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 3,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Carl Gustav Carus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel R. Heller, University Hospital Carl Gustav Carus
- Investigators
- Axel R. Heller, MD, Principal investigator, University Hospital Dresden, GERMANY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461133
- Sponsor's protocol ID
- DrePaSiNet
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
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 22998715Ludikhuize 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 26317569Muller 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 24686020Subbe 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 at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Deteriorating Patients on Peripheral Surgical Wards by an Automated Notification System
- ClinicalTrials.gov ID
- NCT03461133
- Acronym / sponsor ID
- DrePaSiNet
- Conditions
- Safety Issues, Emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,827 participants (actual)
- Lead sponsor
- University Hospital Carl Gustav CarusUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 9 Mar 2018 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | – | –All patients admitted to the participating surgical wards from 2015-01-01 to 2015-12-31 |
| Intervention | – | Other: InterventionAll patients admitted to the participating surgical wards from 2016-07-01 to 2017-06-30 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General surgery, vascular surgery, thoracic surgery,
Key inclusion criteria (1 listed)
- Admission to one of the participating wards
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Automated early warning score and notification systemThe 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. | Other | Intervention |
Primary outcome
In hospital cardiac arrests
Time frame: on average 14 days per patient, cumulative over 12 months in each observed cohort
Patient cardiac arrests during stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Background: PubMed 22998715Pearse 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.
- Background: PubMed 26317569Ludikhuize 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.
- Background: PubMed 24686020Muller 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.
- Background: PubMed 28288655Subbe 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.
- Individual participant dataSharing planned: No. No individual participant data will 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.
Axel R. Heller, MD principal investigator
University Hospital Dresden, GERMANY
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 Safety Issues and Emergencies, run by University Hospital Carl Gustav Carus at 1 site in Germany.
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: finished, as of the sponsor's last update on 9 Mar 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In hospital cardiac arrests (time frame: on average 14 days per patient, cumulative over 12 months in each observed cohort). 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 NCT03461133, which also lists 4 linked publications.
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 9 Mar 2018.