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N/A N=80 Other

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

Morbid Obesity · Surgery

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Utility of ORi Providing Added Warning Time — 46.5; 87.0 seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Rainbow sensor (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Masimo Corporation
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Utility of ORi Providing Added Warning Time
46.5; 87.0

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.

Eligibility Criteria

Inclusion Criteria

  • Age greater than 18 years
  • BMI>30, 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03021551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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