Back to resultsOxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
Primary Purpose
Morbid Obesity, Surgery
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Rainbow sensor
Sponsored by
About this trial
This is an interventional other trial for Morbid Obesity focused on measuring oxygen, desaturation, obesity
Eligibility Criteria
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
Sites / Locations
- UC Davis Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rainbow sensor
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03021551
Brief Title
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
Official Title
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Surgery
Keywords
oxygen, desaturation, obesity
7. Study Design
Primary Purpose
Other
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rainbow sensor
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Rainbow sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utility of ORi Providing Added Warning Time
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26545146
Citation
Shah U, Wong J, Wong DT, Chung F. Preoxygenation and intraoperative ventilation strategies in obese patients: a comprehensive review. Curr Opin Anaesthesiol. 2016 Feb;29(1):109-18. doi: 10.1097/ACO.0000000000000267.
Results Reference
background
PubMed Identifier
1984382
Citation
Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg. 1991 Jan;72(1):89-93. doi: 10.1213/00000539-199101000-00016.
Results Reference
background
PubMed Identifier
26164643
Citation
Bodily JB, Webb HR, Weiss SJ, Braude DA. Incidence and Duration of Continuously Measured Oxygen Desaturation During Emergency Department Intubation. Ann Emerg Med. 2016 Mar;67(3):389-95. doi: 10.1016/j.annemergmed.2015.06.006. Epub 2015 Jul 9.
Results Reference
background
PubMed Identifier
27007078
Citation
Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep;123(3):626-33. doi: 10.1213/ANE.0000000000001262.
Results Reference
background
PubMed Identifier
26978143
Citation
Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, Ezri T. Oxygen Reserve Index: A Novel Noninvasive Measure of Oxygen Reserve--A Pilot Study. Anesthesiology. 2016 Apr;124(4):779-84. doi: 10.1097/ALN.0000000000001009.
Results Reference
background
PubMed Identifier
32424516
Citation
Tsymbal E, Ayala S, Singh A, Applegate RL 2nd, Fleming NW. Study of early warning for desaturation provided by Oxygen Reserve Index in obese patients. J Clin Monit Comput. 2021 Aug;35(4):749-756. doi: 10.1007/s10877-020-00531-w. Epub 2020 May 18.
Results Reference
derived
Learn more about this trial
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
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