Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns (PS)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
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Healthy Infants |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official 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? |
- Potassium Measurements [ Time Frame: 0-30 minutes after start of surgery ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 55 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Infants Less than or equal to 6 mos. of age
Infants Less than or equal to 6 mos. of age
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Detailed Description:
This study is a prospective observational 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.
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Contact: Mohammed Ali, MD | 7135006194 | mohammed.ali@uth.tmc.edu |
| Contact: Sam Li, MD | 7135006186 | Sam.k.li@uth.tmc.edu |
| United States, Texas | |
| Memorial Hermann Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Mohammed Ali, MD 713-500-6194 Mohammed.ali@uth.tmc.edu | |
| Contact: Sam Li, MD 7135006186 sam.k.li@uth.tmc.edu | |
| Principal Investigator: Samia Khalil, MD | |
More Information
No publications provided
| Responsible Party: | Dr. Samia Khalil, Memorial Hermann Hospital |
| ClinicalTrials.gov Identifier: | NCT01349218 History of Changes |
| Other Study ID Numbers: | HSC-MS-10-0180 |
| Study First Received: | May 3, 2011 |
| Last Updated: | May 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Potassium Infants Heel Stick Less than or equal to 6 months of age |
IV catheter blood samples perioperatively elective surgical procedures |
ClinicalTrials.gov processed this record on May 23, 2013