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

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Masimo

Status

Completed

Conditions

Surgery
Morbid Obesity

Treatments

Device: Rainbow sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT03021551
FLEM0004

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Rainbow sensor
Experimental group
Treatment:
Device: Rainbow sensor

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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