Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03030833
Other study ID # QATP3040
Secondary ID
Status Completed
Phase N/A
First received January 23, 2017
Last updated August 31, 2017
Start date February 6, 2017
Est. completion date April 30, 2017

Study information

Verified date January 2017
Source Nonin Medical, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to assess device performance in the presence of carbon monoxide.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 30, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- The subject is male or female.

- The subject is of any racial or ethnic group.

- The subject is between 18 years and 50 years of age (self-reported).

- The subject does not have significant medical problems (self-reported).

- The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

- Exclusion Criteria:

- Has a BMI greater than 30.0 (calculated from self-reported weight and height).

- Has had any relevant injury at the sensor location site (self-reported).

- Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).

- Has a known respiratory condition (self-reported).

- Is currently a smoker (self-reported).

- Has a known heart or cardiovascular condition (self-reported).

- Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).

- Is female and actively trying to get pregnant (self-reported).

- Has a clotting disorder (self-reported).

- Has Raynaud's Disease (self-reported).

- Is known to have anemia (hemoglobin value below lower range of normal for gender)

- Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).

- Is known to have a inherited or congenital methemoglobinemia (self-reported).

- Has unacceptable collateral circulation from the ulnar artery (based on exam).

- Is unwilling or unable to provide written informed consent to participate in the study.

- Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pulse Oximeter
Comparison of pulse oximetry to blood gas analyzer.

Locations

Country Name City State
United States HPPL Duke Univeristy Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Carboxyhemoglobin accuracy Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device. Through study completion, an average of 3 months.
See also
  Status Clinical Trial Phase
Completed NCT03669848 - Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
Completed NCT04656912 - Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
Recruiting NCT04975867 - Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning N/A
Terminated NCT01100515 - Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning Phase 3
Terminated NCT01099995 - Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning Phase 3
Terminated NCT03017742 - Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department
Terminated NCT01059708 - Outcome Following Carbon Monoxide Poisoning in Children N/A
Recruiting NCT05591300 - Microparticles Blood Level in Acute Carbon Monoxide Poisoning
Not yet recruiting NCT04475263 - Cognitive and Blood Biomarker Assessment After CO Exposure
Completed NCT03926494 - Carbon Monoxide-induced Coma: Prognostic Factors
Recruiting NCT02375126 - Normal Quantitative EEG (qEEG) Dataset
Completed NCT03342209 - Utility of High Flow Nasal Cannula in CO Toxicity N/A
Completed NCT00465855 - One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning Phase 4
Recruiting NCT04490317 - CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Withdrawn NCT04118491 - Hyperbaric Oxygen for Carbon Monoxide Induced Chronic Encephalopathy N/A
Unknown status NCT00841165 - Carbon Monoxide Monitoring and Emergency Treatment N/A
Withdrawn NCT00280579 - Cyanide Poisoning in Fire Victims N/A
Enrolling by invitation NCT02483650 - Hyperbaric Oxygen Therapy Registry
Completed NCT05088005 - Prognostic Biomarkers in CO Poisoning
Recruiting NCT02860455 - Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting N/A