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Completed

NCT Number: NCT01349218

Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns

The purpose of this study is to find out whether there is a correlation (link) between the level of potassium in blood samples drawn from a vein and those drawn from a heel stick in infants scheduled for elective surgery.

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

This is a prospective study which will take place at the Children's Memorial Hermann Hospital Operating Room.

After obtaining written informed consent from parents or guardians, infants and babies scheduled to have elective surgery under routine general anesthesia and are <6 months of age will be included in the study. After the baby receives routine general anesthesia, a small amount of blood, 0.5 ml, will be drawn from a vein when an I.V. is started for the surgery. The largest possible cannula will be placed whenever possible to decrease hemolysis. If a baby has a central line, the blood sample will be drawn from it. If a baby has an existing peripheral I.V., a blood sample will be drawn from the I.V. cannula only if blood is freely running, to avoid hemolysis.

Blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml, will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis. The heel will be properly sterilized, and a proper size lancet will be used. The same operator will be performing the heel stick in each case.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants and babies, ASA physical Status I-III, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at Children's Memorial Hermann Hospital will be included.

Exclusion criteria

  • Babies and infants with documented anemia (< 8 gm), who are bleeding, ASA Classification >III, have sickle cell disease or trait, thalassemia, HIV or DIC will be excluded from the study. Babies with organ failure will be excluded.

Treatment and study plan

Blood sample drawn from a vein

Other

0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis.

Blood sample drawn from a heel stick

Other

A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.

Primary outcomes

  1. Potassium Measurements

    Time frame: 0-30 minutes after start of surgery

    In this prospective study, we would like to evaluate whether there is a correlation between the potassium level in blood samples drawn from a vein and those drawn from a heel stick.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Memorial Hermann Hospital

Registry information

Official study title

In Infants and Newborns, is There a Relation Between the Potassium Level in Blood Samples Drawn From a Vein and Those Drawn From a Heel Stick?

Acronym: PS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 6, 2011
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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