Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Hypoxia Clinical Trial

Official title:

Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253785
• Other study ID #: STER05
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: December 2, 2010
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: December 2010
• Source: SterilMed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.

Description:

The testing is conducted on 10 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.

An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Non-smoker

• 18 years or older

• Meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels

• Understand and provide signed consent for the procedure

Exclusion Criteria:

• Smoker

• User of illegal drugs

• Hypertension

• Respiratory disease

• Known allergy to Lidocaine or its derivatives

• Those suffering from upper respiratory infection on the day of study

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoxia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SterilMed, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 Accuracy Verification Study (Arms) of = 3.0% between 70-100%		During Analysis - data were collected for all subjects on one day	No