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

Completed

• Conditions: Surgery; Morbid Obesity
• Interventions: Device: Rainbow sensor

• Registration Number: NCT03021551
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-16
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Disposition First Submitted: 2020-02-25
• Disposition First Submitted QC: 2021-02-24
• Results First Submitted: 2022-02-23
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Results First Posted: 2022-04-19
• Disposition First Posted: 2022-04-19
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rainbow sensor	Rainbow sensor	-

Primary Outcome Measures

Name	Time	Method
Utility of ORi Providing Added Warning Time	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).

Trial Locations

Locations (1)

UC Davis Health; 🇺🇸 Sacramento, California, United States