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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04976504
Other study ID # 2019-06-1-018CC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date October 30, 2019

Study information

Verified date July 2021
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Oxygen reserve index
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.

Locations

Country Name City State
Taiwan Department of Anesthesiology, Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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;:. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation between ORi and PaO2 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. From time of starting preoxygenation until the time of SpO2 90%, assessed up to 20 minutes
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