NCT02299752

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

November 13, 2014

Last Update Submit

November 20, 2014

Conditions

CatheterizationContamination

Outcome Measures

Primary Outcomes (1)

  • visible puncture

    Checking gloves for visible damage in the course of cannulation during resuscitation

    1 day

Secondary Outcomes (1)

  • WLT

    1 day

Study Arms (1)

Catheterization

EXPERIMENTAL

Blood vessel Catheterization during resuscitation with single and double - gloving system. Catheterization was performed using simulation mannikin

Procedure: single-gloving systemProcedure: double-gloving system

Interventions

single-gloving systemPROCEDURE

single-gloving system was used during Catheterization

Catheterization
double-gloving systemPROCEDURE

double-gloving system was used during Catheterization. inner and outer gloves were the same size

Catheterization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not meet the above criteria
  • Wrist or low back diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

RECRUITING

Study Officials

  • Lukasz Szarpak

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Kurowski

CONTACT

+48500186225andrzejkurowski987@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 24, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

PL(1)