SpO2 System Accuracy Testing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by GE Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01613222
First received: June 5, 2012
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

A 2 phase study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.


Condition Intervention
Pulse Oximetry
Device: Pulse oximetry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Official Title: SpO2 System Accuracy Testing

Further study details as provided by GE Healthcare:

Estimated Enrollment: 100
Study Start Date: June 2012
Arms Assigned Interventions
Experimental: Pulse oximetry monitoring Device: Pulse oximetry
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent or have a legally authorized representative provide written informed consent
  • Subjects who are 18-45 years of age
  • Subjects must be willing and able to comply with study procedures
  • Subjects who are non-smokers or who have not smoked 2 days prior to consent.

Exclusion Criteria:

  • Subject or a legally authorized representative is unable to provide written inform consent.
  • Subjects that are considered morbidly obese (defined as BMI > 39.5),
  • Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
  • Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
  • Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
  • Subjects with known heart or cardiovascular conditions,
  • Female subjects that are actively trying to get pregnant or are pregnant,
  • Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
  • Subjects with Systolic blood pressure >140mmHg,
  • Subjects with Diastolic blood pressure >100mmHg,
  • Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613222

Contacts
Contact: Jeffrey Conner, RN, BSN 414.477.8374 jeffrey.conner@ge.com

Locations
United States, Colorado
Clinimark Recruiting
Louisville, Colorado, United States, 80027
Contact: Paul Batchelder    303-717-4820    PBatchelder@Clinimark.com   
Principal Investigator: David Ransom, MD         
Sponsors and Collaborators
GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01613222     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0012
Study First Received: June 5, 2012
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014