CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Rainbow sensordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03021551
NCT03021551N/ACompleted
CompareCT.gov

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

Masimo Corporation·interventional·Posted Jan 16, 2017·Updated Apr 19, 2022

In Brief

A clinical study evaluating Rainbow sensor for Morbid Obesity and Surgery. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity, Surgery
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 16, 2017
Enrollment StartSep 15, 2016
Primary CompletionJul 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.5 years ago

Interventions

Rainbow sensordevice

Masimo Radical-7 and Root System with ORi parameter in all subjects are enrolled in the test group and receive an Rainbow sensor during their elective surgery.