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

• Sponsor: St. Jude Children's Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01042613
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Arms: 2
• Duration (Months): 13.9
• Patients Per Site Per Month: 10.5

Study Details

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	N/A

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
• 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: Jan 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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 [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). [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 [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

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• St. Jude Children's Research Hospital

Publications

None provided.

• Responsible Party: St. Jude Children's Research Hospital
• ClinicalTrials.gov Identifier: NCT01042613
• Other Study ID Numbers: ACVEIN
• First Posted: Jan 5, 2010
• Last Update Posted: Dec 7, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by St. Jude Children's Research Hospital: AccuVein AV300 device;; Intravenous cannulation

Study Results

Participant Flow

Recruitment Details	148 total patients were recruited at single institution (SJCRH) study between Jan 13, 2010, and March 03, 2011.
Pre-assignment Detail	148 total patients were enrolled on the study. The report is based on results for 146 patients. Two patients were excluded from this study. One patient was excluded due to MD's decision and the other patient was deemed to be inevaluable after study enrollment (cannula gauge other than 22 were used).

Arm/Group Title	ACVein	Standard
Arm/Group Description	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	(standard technique of insertion of the intravenous cannula)
Period Title: Overall Study
STARTED	72	74
COMPLETED	72	74
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	ACVein	Standard	Total
Arm/Group Description	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	(standard technique of insertion of the intravenous cannula)	Total of all reporting groups
Overall Participants	72	74	146
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.72 (3.72)	5.37 (3.88)	5.54 (3.79)
Sex: Female, Male (Count of Participants)
Female	35 48.6%	43 58.1%	78 53.4%
Male	37 51.4%	31 41.9%	68 46.6%

Outcome Measures

1. Primary Outcome

Title	First Attempt Success Rate of Cannulation
Description	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.
Time Frame	At cannulation

Outcome Measure Data

Analysis Population Description

Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.

Arm/Group Title	ACVein	Standard
Arm/Group Description	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	(standard technique of insertion of the intravenous cannula)
Measure Participants	72	74
Successful first attempt	54 75%	54 73%
Unsuccessful first attempt	18 25%	20 27%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACVein, Standard
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.851
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Difference of the Binomial Proportions
	Estimated Value	.02
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).
Description	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
Time Frame	At cannulation

Outcome Measure Data

Analysis Population Description

Of the 146 patients, two patients were excluded due to missing time records.

Arm/Group Title	ACVein	Standard
Arm/Group Description	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	(standard technique of insertion of the intravenous cannula)
Measure Participants	71	73
Mean (Standard Deviation) [Minutes]	1.48 (.97)	1.26 (.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACVein, Standard
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.105
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.22
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Skin Punctures
Description	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
Time Frame	At cannulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ACVein	Standard
Arm/Group Description	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)	(standard technique of insertion of the intravenous cannula)
Measure Participants	72	74
Mean (Standard Deviation) [Skin punctures]	1.33 (.75)	1.26 (.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ACVein, Standard
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.8
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.07
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	10 minutes per patient
Adverse Event Reporting Description	Enrollment was from January, 2010 through March, 2011. Patients were off study at completion of cannulation.
Arm/Group Title	ACVein		Standard
Arm/Group Description	Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)		(standard technique of insertion of the intravenous cannula)
All Cause Mortality
	ACVein		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ACVein		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/74 (0%)
Other (Not Including Serious) Adverse Events
	ACVein		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/74 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.