Out-of-Hospital Resuscitation in Winterthur - an Outcome... | NCT02625883

Studies
Out-of-Hospital Resuscitation in Winterthur - an Outcome Study

NCT02625883

Sponsor

Kantonsspital Winterthur KSW

Status

Completed

Last Update Posted

Feb 26, 2020Actual

Enrollment

151Actual

Phase

Not provided

Conditions

Resuscitation

Interventions

Interview

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 30, 2017Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Dec 7, 2015

First Submission Date that Met QC Criteria

Dec 7, 2015

First Posted Date

Dec 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2020

Last Update Posted Date

Feb 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will retrospectively examine all patients with out-of-hospital resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the year 2013 with a two year follow-up and a structured interview about Quality of life. Furthermore, the costs generated by the local health system are analysed.

Detailed Description

The Primary objective of this study is to evaluate the Quality of out-of-Hospital resuscitation by the ambulance Service from the Kantonsspital Winterthur including a 2-year follow-up of the survivors. In this follow-up we evaluate the Quality of life by a validated questionnaire.

The following endpoints will be retrospectively analysed:

time-to-Response Interval; Initial cardiac rhythm; medications given; number of Defibrillations; return of spontaneous circulation, Overall costs for the local health System

Furthermore length of hospital-stay, survival until Hospital discharge, one-year survival, Quality of life two years after resuscitation and total costs will be analysed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survivors		Patients with out-of-Hospital resuscitation and return of spontaneous circulation. Structured interview for quality of life (questionnaire) one year after resuscitation.	Other: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Interview by validated Quality-of-life-questionnaire	Survivors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival after prehospital cardiac Arrest until discharge of Hospital and a one-year follow-up		1 year

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of direct costs of local health care system		1 year
Quality of life one year after resuscitation		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with out-of-hospital resuscitation in Winterthur in the year 2013 and treatment by the emergency medical team from the Kantonsspital Winterthur
Written informed consent of patients for structured interview

Exclusion Criteria:

Patients with resuscitation but death on Scene
no written informed consent from patients for structured interview

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients that were resuscitated out-of-hospital in the year 2013 by the emergency medical team from the Kantonsspital Winterthur.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Ganter, director	sponsor and principal investigator	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31771619	Derived	Ruch R, Stoessel L, Stein P, Ganter MT, Button DA. Outcome, quality of life and direct costs after out-of-hospital cardiac arrest in an urban region of Switzerland. Scand J Trauma Resusc Emerg Med. 2019 Nov 27;27(1):106. doi: 10.1186/s13049-019-0682-7.

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms