N/A
N=80
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
Morbid Obesity · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03021551 ↗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
| Outcome | Result | p-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
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.