A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique

NCT01042613 | Completed Results

• 1 other identifier: ACVEIN
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods.
2. 2.This study will assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.
3. 3.This study will assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.

Conditions

Cannulation

Keywords

AccuVein AV300 device;; Intravenous cannulation

Outcome Measures

Primary Outcomes (1)

• First Attempt Success Rate of Cannulation

  This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.

  At cannulation

Secondary Outcomes (2)

• Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).

  At cannulation

• Number of Skin Punctures

  At cannulation

Study Arms (2)

Group A

OTHER

Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)

Procedure: Cannulation using Accuvein device

Group B

OTHER

(standard technique of insertion of the intravenous cannula)

Procedure: Standard Cannulation method

Interventions

Cannulation using Accuvein device PROCEDURE

If the research participant has been randomized to the AV300 device group A, then intravenous cannulation will be attempted using the AV300 device following manufacturer's instructions by four anesthesiologists.

Group A

Standard Cannulation method PROCEDURE

If the research participant has been randomized to the standard treatment group B then cannulation will be attempted in the standard manner. A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made.

Group B

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Infants and children under 18 years of age.
• American Society of Anesthesiologist (ASA) Physical Status I, II or III.
• Patients undergoing elective surgery,examination under anesthesia,or MRI who do not have existing intravenous access.
• Able to understand English.
• Parent/guardian willing to sign consent.

You may not qualify if:

• Existing intravenous access.
• Malformations or infections at the potential site of insertion.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Need for emergency surgery.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

Results Point of Contact

• Title: Luis Trujillo Huaccho, MD
• Organization: St. Jude Children's Research Hospital

info@stjude.org

1-866-278-5833

Study Officials

• Luis Trujillo Huaccho, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 7, 2011
• Results First Posted: December 7, 2011

Record last verified: 2011-11

Locations

US (1)