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

• ClinicalTrials.gov Identifier: NCT01042613
• Recruitment Status: Completed
• First Posted: January 5, 2010
• Results First Posted: December 7, 2011
• Last Update Posted: December 7, 2011
• Sponsor: St. Jude Children's Research Hospital
• Information provided by (Responsible Party): St. Jude Children's Research Hospital

Study Description

Brief Summary:

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. 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. 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.

Condition or disease	Intervention/treatment	Phase
Cannulation	Procedure: Cannulation using Accuvein device; Procedure: Standard Cannulation method	Not Applicable

Detailed Description:

Patients agreeing to participate in this study will be randomized to one of two groups for intravenous access. One group will use the standard cannulation method and the other group will use the new FDA approved AccuVein AV300 device for cannulation.

After pre-anesthetic evaluation, the research participant will be brought to the operating room or magnetic resonance imaging (MRI) Suite and standard monitoring will be applied (EKG, SpO2, BP) if tolerated. Anesthesia will be induced via a face mask with sevoflurane in 100% O2. When the supervising anesthesiologist deems it appropriate, attempt at cannulation will begin.

A tourniquet will be applied. A 22-gauge cannula will be used. Randomization will take place before the patient is taken back to the Operating Room or MRI Suite. If the research participant has been randomized to the standard treatment group then cannulation will be attempted in the standard manner. If the research participant has been randomized to the AV300 device group then intravenous cannulation will be attempted using the AV300 device following the manufacturer's instructions.

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.

Only the study coordinator will know which randomization group the patient has been assigned. Once the anesthesiologist has determined a potential IV access site, s/he will be informed to which group the patient was assigned. If the parent/guardian requests, s/he will be told after the procedure to which group the child was randomized.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique
• Study Start Date: January 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Group A; Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	Procedure: Cannulation using Accuvein device; 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 B; (standard technique of insertion of the intravenous cannula)	Procedure: Standard Cannulation method; 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.

Outcome Measures

Primary Outcome Measures :

1. First Attempt Success Rate of Cannulation [ Time Frame: At 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.

Secondary Outcome Measures :

1. Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes). [ Time Frame: At cannulation ]
   To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique
2. Number of Skin Punctures [ Time Frame: At cannulation ]
   To 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

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Tennessee

St . Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

• Principal Investigator: Luis Trujillo Huaccho, MD; St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital 

• Responsible Party: St. Jude Children's Research Hospital
• ClinicalTrials.gov Identifier: NCT01042613
• Other Study ID Numbers: ACVEIN
• First Posted: January 5, 2010
• Results First Posted: December 7, 2011
• Last Update Posted: December 7, 2011
• Last Verified: November 2011

Keywords provided by St. Jude Children's Research Hospital:

AccuVein AV300 device; Intravenous cannulation