Correlation of Arterial Blood Gas (ABG) and Venous Blood... | NCT01287884

Studies
Correlation of Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) in the Undifferentiated Critically Ill Patient

NCT01287884

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Nov 9, 2012Estimated

Enrollment

156Actual

Phase

Not Applicable

Conditions

Patients Needing Blood Gases

Interventions

Venous Blood Gas

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jan 31, 2011

First Submission Date that Met QC Criteria

Jan 31, 2011

First Posted Date

Feb 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2012

Last Update Posted Date

Nov 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to identify a correlation between the pH and pCO2 in arterial and venous blood. The secondary objectives include a correlation of pulse oximetry and arterial pO2 along with subgroup analyses of specific patient populations such as congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis, pneumonia, overdose, and trauma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Venous Blood Gas	No Intervention	All subjects have an ABG and VBG drawn. No intervention.	Other: Venous Blood Gas

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venous Blood Gas	Other	patients who have been identified by the treating physician as needing an ABG will receive an VBG is they consent to take part in the study	Venous Blood Gas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree to which pH and pCO2 correlate between ABG and VBG	ABG and VBG will be obtained 5 minutes apart and compared	5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older Signed consent Patient in the ED or ICU Have a disease state that necessitates obtaining an ABG Have a disease state that necessitates pulse oximetry monitoring

Exclusion Criteria:

Any contraindication to arterial or venous blood draw Prior enrollment in the study during the current hospitalization Pregnancy Prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eli Zeserson, MD	Christiana Care Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health Services		Newark	Delaware	19718	United States