NCT02888431

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

August 17, 2016

Last Update Submit

January 30, 2017

Conditions

Keywords

pHbase deficitlactate valuesvenous blood samplesarterial blood samples

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Arterial blood sample

0.5 mL blood sample from arterial line which is clinically indicated

Device: bedside point-of-care device

peripheral venous blood sample

0.5 mL blood sample drawn simultaneously with arterial sample from clinically indicated peripheral line

Device: bedside point-of-care device

Interventions

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

Arterial blood sampleperipheral venous blood sample

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients who not require arterial access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Joseph Tobias

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman, Professor of Anesthesiology

Study Record Dates

First Submitted

August 17, 2016

First Posted

September 5, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations