NCT01513213

Brief Summary

The purpose of this study is to evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

January 5, 2012

Last Update Submit

January 20, 2017

Conditions

Neurosurgery

Keywords

Arterial cannulationBlood gasCarbon dioxideArterial bloodOxygenOxygen fractions

Outcome Measures

Primary Outcomes (1)

  • Correlate the level of carbon dioxide within arterial blood to inspired and expired oxygen gradient.

    Compare the levels of carbon dioxide found in the patient's blood to the amounts of carbon dioxide and oxygen in the air that the patient inhales and exhales. If a relationship exists between the levels of carbon dioxide in the blood and the levels of carbon dioxide and oxygen inhaled and exhaled by the patient, anesthesiologists will be able to use this relationship to adjust ventilators during anesthesia without having to take blood from an artery.

    At least 2 hours

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults age 18 to 65 scheduled for a surgical procedure that will last at least two hours and for whom arterial cannulation and at least two arterial blood gas analyses are planned during the surgery.

You may qualify if:

  • Age 18 to 65.
  • Scheduled for surgical procedure that will last at least 2 hours.
  • Arterial cannulation is planned because of either the complexity of the surgery or patient comorbidity.
  • At least two arterial blood gas analyses are planned during the surgery.

You may not qualify if:

  • No arterial cannulation is necessary or planned for the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Study Officials

  • Arthur M Lam, MD, FRCPC

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 20, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2014

Study Completion

December 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(1)