- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04976504
Early Warning for Desaturation by Oxygen Reserve Index
Early Warning for Desaturation by Oxygen Reserve Index During Induction of General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an observational study of the routine clinical practice with no specific additional interventions required.
The investigators enrolled the American Society of Anesthesiologists (ASA) physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. Patients were positioned supine on the operating room table. Standard monitors and the ORi sensor were placed. The patients were preoxygenated with a facemask (flow rate of 8 to 10 liters/minute) for 3 minutes with spontaneous ventilation. Propofol (2-2.5 mg/kg), fentanyl (2-3 mcg/kg) and rocuronium (0.6-0.9 mg/kg) were administrated to achieve anesthesia induction during following 3 minutes. The patient was keeping ventilated manually by the anesthesiologist during the induction phase and intubated under direct visualization with a video-assisted laryngoscope at 6 minutes. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. The patients remained apneic. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds. Arterial blood is sampled every minute, from preoxygenation to resumed ventilation, to observe blood oxygen concentration changes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan, 112
- Department of Anesthesiology, Taipei Veterans General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia.
Exclusion Criteria:
- Age <18 years
- Inability to give primary consent
- Pregnancy
- History of chronic obstructive pulmonary disease (COPD)
- History of asthma
- Suspected difficult intubation
- Preoperative hemoglobin less than 10 mg/dl.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oxygen reserve index
Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia and did not match the exclusion criteria.
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This is an observational study of the routine clinical practice with no specific additional interventions required.
The investigators enrolled the ASA physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction.
ORi and standard monitors were placed.
The patients were preoxygenated and received anesthesia induction as routine clinical practice.
Intubation was done by video-laryngoscope.
The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation.
Ventilation was resumed when SpO2 fell to 90%.
ORi and SpO2 were recorded every ten seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional warning time provided by ORi trigger
Time Frame: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
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The ORi peak warning time was defined as the duration from ORi decreased by 0.05 from the plateau or peak values until SpO2 decreased to 90%.
The ORi 0.55 warning time was defined as the duration from the ORi value was 0.55 to SpO2 90%.
The SpO2 waring time was defined as the duration from SpO2 98% to 90%.
The added warning time provided by ORi peak or ORi 0.55 was defined as the difference between ORi peak warning time, ORi 0.55 warning time, and SpO2 warning time.
The investigators will check the duration of the additional warning time provided by the ORi trigger.
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From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between ORi and PaO2
Time Frame: From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
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The Oxygen Reserve Index is a dimensionless parameter between 0 and 1 that is related to real-time oxygenation reserve status in the moderate hyperoxic range (PaO2 of about 100 to 200 mmHg).
The investigators will check the correlation between ORi and PaO2 in our study.
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From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8. Review. Erratum in: J Clin Monit Comput. 2018 Feb 14;:.
- 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.
- Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109.
- Cheng HW, Yeh CY, Chang MY, Ting CK, Chang PL. How early warning with the Oxygen Reserve Index (ORi™) can improve the detection of desaturation during induction of general anesthesia? J Clin Monit Comput. 2022 Oct;36(5):1379-1385. doi: 10.1007/s10877-021-00776-z. Epub 2021 Dec 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-06-1-018CC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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