Morbid Obesity, Surgery
Conditions
Keywords
oxygen, desaturation, obesity
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.
Interventions
DEVICERainbow sensor
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.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rainbow Sensor Rainbow sensor: 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. | 77 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment Issues | 2 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Rainbow Sensor | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 24 Participants | — |
| Age, Categorical Between 18 and 65 years | 53 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 77 participants | — |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 77 |
| other Total, other adverse events | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 |
Outcome results
Primary
Utility of ORi Providing Added Warning Time
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).
Time frame: 1 year
Population: In 4 subjects, the device failed initial calibration. In another subject, clinical care constraints precluded completion of the data collection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rainbow Sensor | Utility of ORi Providing Added Warning Time | Added warning time in Obese | 46.5 seconds |
| Rainbow Sensor | Utility of ORi Providing Added Warning Time | Added warning time in Normal BMI | 87.0 seconds |