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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02888431
Other study ID # IRB15-00793
Secondary ID
Status Completed
Phase N/A
First received August 17, 2016
Last updated January 30, 2017
Start date September 2015
Est. completion date December 2016

Study information

Verified date January 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.

Exclusion Criteria:

- Patients who not require arterial access.

Study Design


Intervention

Device:
bedside point-of-care device
A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary lactate blood value blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the lactate value will be assessed by using a bedside point-of-care device, called i-stat. During surgery- approximately 15-20 minutes after induction in the operating room (OR)
Primary base deficit blood value blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the base deficit blood value will be assessed by using a bedside point-of-care device, called i-stat. During surgery- approximately 15-20 minutes after induction in the operating room (OR)
Primary pH blood value blood will be drawn from peripheral venous line, arterial line, and/or central venous line then pH blood value will be assessed by using a bedside point-of-care device, called i-stat. During surgery- approximately 15-20 minutes after induction in the operating room (OR)
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