Blood Sampling Through Peripheral Venous Catheter in Infants

NCT ID: NCT01119911

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-06-30

Brief Summary

We hypothesize that peripheral venous catheter used for fluid administration can replace venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under 2 years of age.

Detailed Description

Multiple venipunctures in hospitalized children result in physical and emotional distress. Recently, we have found that blood sampling via peripheral venous catheter used for fluid administration in children significantly reduces pain and, except for glucose, can replace venipuncture for determining complete blood count and basic chemistry analytics, including white and red blood cell counts, hemoglobin and hematocrit levels, mean corpuscular volume, mean corpuscular hemoglobin level, red blood cell distribution width, platelet count, mean platelet volume, and sodium, potassium, chloride, and urea levels (Berger-Achituv S, Budde-Schwartzman B. Ellis MH, Shenkman Z. Erez I. Blood Sampling through Peripheral Venous Catheters for Selected Basic Analytes in Children. Pediatrics. In press).

The goal of this study is to investigate whether blood sampling via peripheral venous catheter used for fluid administration can significantly reduces pain and replace venipuncture for determining complete blood count and basic chemistry analytics in infants under 2 years of age.

Conditions

Pain

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

Blood sampling from peripheral venous catheter.

Venipuncture is performed on the opposite limb of the peripheral venous catheter. Within 3 minutes, a second sample is taken from existing peripheral venous catheter used for fluid administration. Intravenous fluids are then stopped for 30 seconds and a tourniquet applied proximal to the device for another 30 seconds. A 2-mL syringe is attached and 0.5 mL of blood aspirated and discarded. Thereafter, 2 mL blood is slowly drawn during about 15 seconds, into a different 2-mL syringe, to allow a gentle pumping action that may reduce vacuum in the syringe and thus hemolysis rates. Afterwards, the intravenous device is flushed with 2 mL normal saline and infusion restarted.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Infants under 2 years of age.
• Only hemodynamically stable infants.
• Infants with peripheral venous catheter present for less than 72 hours.
• At least 20 mL of fluids have been infused intravenously at the time of blood sampling.

Exclusion Criteria

• Infants with signs of catheter-related thrombophlebitis.

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sivan Berger-Achituv, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Ilan Erez, Dr

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Erez Ilan, MD

Role: CONTACT

erezi@clalit.org.il

972-9-7472344

Other Identifiers

MMC10086-09CTIL

Identifier Type: -

Identifier Source: org_study_id