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Clinical Trials/NCT03021551
NCT03021551
Completed
Not Applicable

Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients

Masimo Corporation1 site in 1 country80 target enrollmentSeptember 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Masimo Corporation
Enrollment
80
Locations
1
Primary Endpoint
Utility of ORi Providing Added Warning Time
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to partial pressure of oxygen (PaO2) values of 100 mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200 mmHg and above. This is clinical study designed to evaluate the clinical utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin desaturation during the induction of general anesthesia and tracheal intubation in obese patients undergoing elective surgical procedures.

Registry
clinicaltrials.gov
Start Date
September 15, 2016
End Date
July 20, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age greater than 18 years
  • BMI\>30, \<40 m/kg2
  • Control group only: BMI \>18.5 m/kg2, \<25 m/kg2
  • Scheduled for an elective surgical procedure requiring general anesthesia and endotracheal intubation
  • Exclusion Criteria
  • Age less than 18 years
  • Adults unable to give primary consent
  • Pregnancy
  • Prisoners

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Utility of ORi Providing Added Warning Time

Time Frame: 1 year

Evaluate the clinical utility of the change in the oxygen reserve index as an early warning of impending arterial oxygen desaturation in Obese patients (30 \< BMI \< 40 kg m-2) and Normal BMI patients (19 \< BMI \< 25 kg m-2).

Study Sites (1)

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