Safety Improvement and Checklist Application | NCT01343069

Studies
Safety Improvement and Checklist Application

NCT01343069

Sponsor

Regional Hospital of Bolzano

Status

Withdrawn

Last Update Posted

May 5, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Complications
Outcome

Interventions

implementation surgical checklist

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

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient quality of data

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Apr 26, 2011

First Submission Date that Met QC Criteria

Apr 26, 2011

First Posted Date

Apr 27, 2011Estimated

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

May 4, 2015

Last Update Posted Date

May 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Bock, Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center, Regional Hospital of BolzanoPrincipal Investigator

Lead Sponsor

Regional Hospital of BolzanoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
before surgical checklist	No Intervention
after implementation surgical checklist	Active Comparator		Procedure: implementation surgical checklist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implementation surgical checklist	Procedure	a checklist according to the suggestions raised by the WHO is implementated	after implementation surgical checklist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of complications after elective surgery	comparison of number of complications in the two study arms before and after introduction of the checklist	within 30 days

Secondary Outcomes

Measure	Description	Time Frame
mortality	evaluation of 30-days mortality	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery in general or regional anesthesia lasting > 15 min

Exclusion Criteria:

urgent surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided