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

NCT ID: NCT03021551

Last Updated: 2022-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-15

Study Completion Date

2018-07-20

Brief Summary

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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

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Conditions

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Morbid Obesity Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Rainbow sensor

Group Type EXPERIMENTAL

Rainbow sensor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Davis Health

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26545146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1984382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26164643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27007078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26978143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32424516 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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FLEM0004

Identifier Type: -

Identifier Source: org_study_id

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