Clinical Trials Logo
  1. Home
  2. Hyperoxia
  3. NCT03488238
  4. Details
NCT03488238 Clinical Trial

Correlation of Changes in PaO2 and ORi in Adult Patients

Hyperoxia Clinical Trial

Official title:
Correlation of Changes in PaO2 and ORi in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03488238
Other study ID # FLEM0007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date September 19, 2018

Study information
Verified date August 2021
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date September 19, 2018
Est. primary completion date September 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age greater than 18 years - ASA physical status III or IV - Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia Exclusion Criteria: - Age less than 18 years - Adults unable to give primary consent - Pregnancy - Prisoners

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ORi sensor
Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi

Locations
Country Name City State
United States UC Davis Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2. Less than 30 mins
Primary Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2. Less than 30 mins
Primary Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2. Less than 30 minutes
See also
  Status Clinical Trial Phase
Completed NCT04291911 - Retrospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen
Completed NCT02917668 - Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Cardiac Surgery Patients N/A
Not yet recruiting NCT02201875 - Intrinsic Periodic Pattern of Breathing N/A
Completed NCT05770583 - The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia. N/A
Not yet recruiting NCT02553668 - Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression N/A
Completed NCT01978158 - Effects of Oxygen Status on Endotoxemia Induced Inflammation and Hypoxia Inducible Factor-1α Phase 1/Phase 2
Completed NCT03268590 - Neuroimaging During Pure Oxygen Breathing Phase 4
Active, not recruiting NCT04133740 - Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study Phase 4
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Completed NCT05150418 - Supplemental Oxygen in Hypovolemia Phase 1
Terminated NCT03550469 - Computer-assisted Oxygen Therapy Weaning in Critically Ill Children N/A
Recruiting NCT04413097 - Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants N/A
Completed NCT03464695 - Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD N/A
Recruiting NCT04269161 - NICU Oxygen Control Study N/A
Completed NCT02384616 - Hyperoxygenation in Anesthetized Children N/A
Unknown status NCT01348906 - Intermittent Normoxia Reduces Myocardial Reperfusion Injury N/A
Completed NCT04420897 - The Effect of Intraoperative Arterial Oxygen Pressures on Early Post-Operative Patient and Graft Survival in Living Donor Kidney Transplantation
Completed NCT03930979 - The Effect of Hyperoxia on Cardiac Output
Not yet recruiting NCT06326372 - The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients
Recruiting NCT05412810 - Oxidative Lipidomic Biomarkers During Mechanical Ventilation in Critically Ill Patients (OXY-BAL).