Early Warning for Desaturation by Oxygen Reserve Index

NCT04976504 | Completed FDA Device

• 1 other identifier: 2019-06-1-018CC
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

During the induction of general anesthesia, the anesthesiologist needs to provide the oxygen supply to meet the patient's needs continuously. In the clinical scenario, the pulse oximeter is used as a standard to monitor hemoglobin oxygen saturation (SpO2) but is limited to assess the oxygenation status beyond the measurement of 100%. The Oxygen Reserve Index (ORi) is a dimensionless parameter between 0 and 1 that is related to real-time oxygenation reserve status. This study was designed to evaluate the duration of warning time for desaturation provided by different ORi alarm triggers during prolonged apnea in surgical patients. The primary endpoint was the duration of additional warning time provided by the ORi trigger. The secondary endpoint was the correlation of ORi and PaO2.

Conditions

Desaturation of Blood; Anesthesia

Keywords

Oxygen reserve index; Induction of general anesthesia

Outcome Measures

Primary Outcomes (1)

• Additional warning time provided by ORi trigger

  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.

  From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes

Secondary Outcomes (1)

• Correlation between ORi and PaO2

  From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes

Study Arms (1)

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.

Device: Oxygen reserve index

Interventions

Oxygen reserve index DEVICE

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.

Oxygen reserve index

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 27007078 BACKGROUND

• 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.

  PMID: 28791567 BACKGROUND

• 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.

  PMID: 26978143 BACKGROUND

• 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.

  PMID: 32815872 BACKGROUND

• 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.

  PMID: 34953137 DERIVED

Study Officials

• Hung-Wei Cheng, MD

  Taipei Veteran General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 26, 2021
• Study Start: March 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

TW (1)