Blood Sampling Through Peripheral Venous Catheter in Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01119911
First received: May 4, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Pain
Other: Blood sampling from peripheral venous catheter.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Blood Sampling Through Peripheral Venous Catheter for Selected Basic Analytes in Infants

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices. [ Time Frame: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessment of infant's mood during procedures. [ Time Frame: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months. ] [ Designated as safety issue: No ]
    The investigator will record infant's mood (calm, distressed/crying, crying vigorously) during blood sampling from peripheral venous catheter and direct venipuncture.


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: June 2012
Intervention Details:
    Other: 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.
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119911

Contacts
Contact: Erez Ilan, MD 972-9-7472344 erezi@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Sivan Berger-Achituv, MD Meir Medical Center
Principal Investigator: Ilan Erez, Dr Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01119911     History of Changes
Other Study ID Numbers: MMC10086-09CTIL
Study First Received: May 4, 2010
Last Updated: March 16, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Blood sampling
Venipuncture
Peripheral venous catheter
Complete blood count
Basic chemistry
Hemolysis
Peripheral venous catheter replaces venipuncture.
Peripheral venous catheter blood sampling reduces pain.

ClinicalTrials.gov processed this record on October 29, 2014