Blood Sampling Through Peripheral Venous Catheter in Infants

NCT01119911 | Unknown

• 1 other identifier: MMC10086-09CTIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Blood sampling; Venipuncture; Peripheral venous catheter; Complete blood count; Basic chemistry; Hemolysis; Peripheral venous catheter replaces venipuncture.; Peripheral venous catheter blood sampling reduces pain.

Outcome Measures

Primary Outcomes (1)

• To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices.

  Comparisons of complete blood count (including white and red blood cells, hemoglobin, hematocrit, mean corpuscular volume and hemoglobin, red cell distribution width, platelets, mean platelet volume) and basic chemistry indices (including sodium, potassium, glucose, chloride, urea) will be performed and hemolysis will be documented.

  Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.

Secondary Outcomes (1)

• Assessment of infant's mood during procedures.

  Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.

Interventions

Blood sampling from peripheral venous catheter. OTHER

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.

Eligibility Criteria

• Age: 1 Week - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All infants under 2 years of age, admitted to the Departments of Pediatrics and Pediatric Surgery, Meir Medical Center, who have a functioning peripheral venous catheter and require repeated blood sampling for diagnostic purposes.

You may qualify if:

• 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.

You may not qualify if:

• Infants with signs of catheter-related thrombophlebitis.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

RECRUITING

MeSH Terms

Conditions

Pain; Hemolysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Sivan Berger-Achituv, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

• Ilan Erez, Dr

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erez Ilan, MD

CONTACT

972-9-7472344; erezi@clalit.org.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2010
• Study Completion: June 1, 2012
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

IL (1)