Unnoticed Gloves Perforation | NCT02299752

Studies
Unnoticed Gloves Perforation

NCT02299752

Sponsor

International Institute of Rescue Research and Education

Status

Unknown status

Last Update Posted

Nov 24, 2014Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Catheterization
Contamination

Interventions

single-gloving system
double-gloving system

Countries

Poland

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Nov 13, 2014

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 24, 2014Estimated

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

Nov 20, 2014

Last Update Posted Date

Nov 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lukasz Szarpak, Lukasz Szarpak, National Institute of Cardiology, Warsaw, PolandPrincipal Investigator

Lead Sponsor

International Institute of Rescue Research and EducationOTHER

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 aim of the study was to investigate the incidence of glove perforation in cannulation of blood vessels (CBV) during resuscitation and compare perforation rates between single and double-gloves.

Detailed Description

Exposure to blood pathogens among medical staff is a serious problem that should be first and foremost prevented . The risk of acquiring a virus from one percutaneous needle stick is 0.3% to 0.4% for human immunodeficiency virus (HIV), 6% to 30% for hepatitis B (HBV), and 2.7% to 10% for hepatitis C (HCV). The prevention of blood-borne infections is particularly important during cases when emergency medical attention is needed. Emergency Response Personnel that work in this profession have taken medical rescue courses to prepare for situations of sudden health threats, hence the majority of procedures is associated with direct contact with body fluids of the patient.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catheterization	Experimental	Blood vessel Catheterization during resuscitation with single and double - gloving system. Catheterization was performed using simulation mannikin	Procedure: single-gloving system Procedure: double-gloving system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single-gloving system	Procedure	single-gloving system was used during Catheterization	Catheterization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visible puncture	Checking gloves for visible damage in the course of cannulation during resuscitation	1 day

Secondary Outcomes

Measure	Description	Time Frame
WLT	Water leak test was used to checking unnoticed gloves damage	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Give voluntary consent to participate in the study
Medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

Not meet the above criteria
Wrist or low back diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrzej Kurowski	Contact	+48500186225		andrzejkurowski987@gmail.com

Overall Officials

Name	Affiliation	Role
Lukasz Szarpak	Institute of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Institute of Rescue Research and Education	Recruiting	Warsaw	Masovia	03-122	Poland