Evaluation of a Touchless Vein Scanner for Venepuncture and Cannulation in Pediatric Patients (VENSCAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01434537
First received: July 29, 2011
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric operation room setting for a 4 weeks period. Assessment of usability, anonymous clinical register of every venepuncture(age, gender, size, weight, punction site, number of attempts, time until successful cannulation, local anaesthesia, general anaesthesia, pain scales: faces pain scale und BPS/BPOS).


Condition
Venepuncture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Venepuncture and Vein Cannulation With Support of the AccuVein AV300 Vein Scanner in Paediatric Patients in a Pre-operation Setting

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • time until completion of procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    minutes until successful puncture and cannulation of peripheral vein


Secondary Outcome Measures:
  • number of attempts until completion of procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    number of attempts until successful puncture and cannulation of peripheral vein


Enrollment: 238
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
SCAN
Venepuncture performed with support of the AccuVein 300 vein scanner.
NO_SCAN
Venepuncture without support of the vein scanner.

Detailed Description:

For application of drugs and liquids a peripheral venous access is necessary in anaesthesiological procedures.The peripheral venepuncture is a painful procedure and induces a higher level of perioperative stress in children.

The punction of peripheral veins in children can be made difficult by the often distinctive amount of subcutaneous fat or other medical conditions.

The AccuVein ® AV300 vein scanner is a contactless, laser-driven device made for facilitate the search for peripheral veins up to a depth of 7mm. This could lead to a minimization of time until successful puncture and smaller number of failures.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients from 0 to 17 years in a peripoerative setting in the pediatric operation room with need for peripheral venous access.

Criteria

Inclusion Criteria:

  • age from 0 to 17 years
  • perioperative indication for peripheral venous access
  • regular work time of the operation room from 7 am to 4 pm

Exclusion Criteria:

  • age more than 17 years
  • no indication for or already established venous access
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434537

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Claudia Spies, MD, Prof. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia Spies, Prof. , MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01434537     History of Changes
Other Study ID Numbers: VENSCAN
Study First Received: July 29, 2011
Last Updated: September 14, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
pediatric anesthesia
venepuncture
peripheral venous access

ClinicalTrials.gov processed this record on July 22, 2014