Oxygen Reserve Index in One-Lung Ventilation During Elective Thoracic Operations

Oxygen Reserve Index and Its Relations With Primary Hemodynamical and Oximeter Parameters During Elective Thoracic Surgical Operations

The investigators' goal is to perform an observational cohort study investigating the use of oxygen reserve index (ORi) in patients undergoing elective thoracic surgery and one-lung ventilation (OLV). For this purpose, ORi values are recorded and compared to the other collected hemodynamical and oximeter parameters. The primary hemodynamic parameters include heart rate (HR) and blood pressure (BP), while; oximeter device-related parameters include peripheral oxygen saturation, perfusion index (PI), and pleth variability index (PVI).

The investigators' secondary goal is to investigate relationships between these hemodynamical and oximeter parameters using statistical analysis methods.

Study Overview

• Status: Completed
• Conditions: Perfusion Index; One-Lung Ventilation; Hypoxemia During Surgery; Oxygen Reserve Index; Pleth Variability Index
• Intervention / Treatment: Device: Masimo Radical-7 Pulse CO-Oximeter

Detailed Description

The main objective of this study is to investigate the possible benefits of using the oxygen reserve index (ORi) parameter during one-lung ventilation (OLV) and elective thoracic operations. For this purpose, ORi values are compared to primary hemodynamical parameters of blood pressure (BP) and heart rate (HR) and Meanwhile, a device from Masimo Inc, USA, provides oximeter-related parameters, including peripheral oxygen saturation, perfusion index (PI), and pleth variability index (PVI). The secondary objective is to investigate possible statistically significant correlations between these hemodynamical and oximeter parameters using appropriate statistical methods.

The study participants are patients undergoing video-assisted thoracotomy surgical procedures (VATS) or open thoracotomy for suspicion and possible lung tumor removal. The surgical operation of either lobectomy, pneumonectomy, lung biopsy, or wedge resection is considered during this procedure. The inclusion and exclusion criteria are summarized in another section of the clinicaltrials.gov registration document. All patients in the study receive a similar anesthetic management protocol. Premedication is not required in the study. After admitting a patient to the operating theatre, pulse oximetry SpO2, electrocardiogram, and noninvasive blood pressure monitoring are established. Heart rate (HR), mean arterial pressure (MAP), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are measured at certain time points. Anesthesia requires induction of anesthesia with intravenous doses of propofol (Pofol, Fresenius Pharmaceutical, Turkey), 2 to 3 mg/kg, rocuronium (Esmeron, Organon Pharmaceuticals, U.S.A.) at a dose of 0.6 mg/kg, and fentanyl (Janssen fentanyl, Janssen Pharmaceutical, Belgium) at a dose of 2 to 3 mcg/kg. Tracheal intubation requires the use of a left Robertshaw double-lumen tube. During anesthesia, one-lung ventilation (OLV) is provided to all patients in addition to mechanical ventilation. The anesthesia maintenance includes inhalational anesthetic of sevoflurane (Sevorane, Abbott Pharmaceutical, USA) at an end-tidal concentration of 1 to 2% to provide a sufficient minimum alveolar concentration to establish anesthesia and intravenous fentanyl boluses at a dose of 0.2 mcg/kg every hourly to provide analgesia and to keep mean arterial blood pressure between 60 and 80 mmHg. In addition to standard follow-up parameters, oxygen reserve index (ORi), perfusion index (PI), pleth variability index (PVI) is monitored for each patient at certain time points. Hypoxemia during OLV was defined as peripheral oxygen saturation (SpO2) value of less than 95% when the inspired oxygen fraction (FiO2)value is equal to or greater than 60% on a pulse oximetry device. Hemodynamic and oximeter data were continuously monitored. The parameters that are in need of investigation include; MAP, SBP, DBP, HR, SpO2, PaO2, ORi, PI, and PVI values. These data are monitored at thirteen different time points during the period of anesthesia induction and maintenance of the surgery. The device used in this study is called the Radical-7 Pulse CO-Oximeter device for the measurement of ORi, PI, and PVI. A correlation between these values was investigated on the continuous graphs. The duration of surgery, anesthesia, OLV, and total 100% oxygen application time are recorded. Blood gas analysis was provided at DL5 at a 5-minute time point and blood gas analysis was performed for prolonged surgeries and for surgeries with high bleeding performance that required other analysis. Routinely, patients are ventilated with 50% FiO2 (50% oxygen + 50% air mixture, 1 liter/minute fresh gas flow) after induction. The value of FiO2 rises depending on pulse oximeter values between the values of 60% and 100% in order to keep SpO2 values greater than 94. The incidence of thromboembolic complications, arrhythmia, pneumonia, the duration of hospital and intensive care unit stay is recorded.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22030
    • Trakya University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

From a total of fifty-nine patients, 50 patients underwent either video-assisted thoracic surgery or open thoracotomy after a diagnosis of a suspicious lung tumor.

Description

Inclusion Criteria:

• All patients at ages between 22 to 80 years old,
• American Society of Anesthesiologists Physical Status (ASA-PS) risk groups of 1 to 3
• Elective thoracic surgery
• Operational types of thoracic surgery include; either open lung resection with thoracotomy or video-assisted thoracic surgery (VATS) operative procedure along with general a anesthesia, DLT insertion, and OLV for all patients

Exclusion Criteria:

• Refusal to participate in a study,
• History of severe asthma,
• Severe renal and hepatic insufficiencies,
• Pregnancy,
• History of previous pulmonary resection,
• Hemoglobinopathies.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Outcome Measure-(1)	Baseline time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Baseline time point after patient's arrival into operating room before anesthesia induction during elective thoracic operation
Main Outcome Measure-(2)	Preoxygenatiom time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Preoxygenation time point before anesthesia induction during elective thoracic operation
Main Outcome Measure-(3)	Third time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Third time point during thoracic operation defined as; five minutes after tracheal intubation during two-lung ventilation in the supine position during elective thoracic operation
Main Outcome Measure-(4)	Fourth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Fourth time point during thoracic operation defined as; 5 minutes after placing the patient in a lateral position with two-lung ventilation during elective thoracic operation
Main Outcome Measure-(5)	Fifth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Fifth time point during thoracic operation defined as; at 1 minute after OLV placement during elective thoracic operation
Main Outcome Measure-(6)	Sixth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Sixth time point during thoracic operation defined as; at 2 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(7)	Seventh time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Seventh time point during thoracic operation defined as; at 5 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(8)	Eighth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Eighth time point during thoracic operation defined as; at 10 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(9)	Ninth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Ninth time point during thoracic operation defined as; at 15 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(10)	Tenth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Tenth time point during thoracic operation defined as; at 30 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(11)	Eleventh time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Eleventh time point during thoracic operation defined as; at 45 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(12)	Twelfth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Twelfth time point during thoracic operation defined as; at 60 minute after OLV placement during elective thoracic operation.
Main Outcome Measure-(13)	Thirteenth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation	Thirteenth time point during thoracic operation defined as; at 90 minute after OLV placement during elective thoracic operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome-(1)	A correlation between ORi and peripheral oxygen saturation (SpO2), ORi and perfusion index (PI), and ORi pleth variability index (PVI) parameters that we collected during operation in patients undergoing elective thoracic surgery and one-lung ventilation (OLV)	During anesthesia induction and maintenance of elective thoracic operation
Secondary Outcome-(2)	The Patients' demographic parameters and co-morbid diseases	Twenty-four hours prior to elective thoracic surgery operation
Secondary Outcome-(3)	Measurement of mean arterial pressure (MAP)	During elective thoracic surgery every five minutes continuously
Secondary Outcome-(4)	Measurement of systolic blood pressure (SBP)	During elective thoracic surgery every five minutes continuously
Secondary Outcome-(5)	Measurement of diastolic blood pressure (DBP)	During elective thoracic surgery every five minutes continuously
Secondary Outcome-(6)	Measurement of heart rate (HR)	During elective thoracic surgery every five minutes continuously
Secondary Outcome-(7)	Arterial blood gas analysis during elective thoracic surgical operation	Five minutes after placing the patient in a lateral position with two-lung ventilation

Collaborators and Investigators

• Sponsor: Trakya University
• Investigators: Study Chair: Hasan Umit, MD, Trakya University, Trakya University Training and Research Hospital, Edirne, Turkey, 22030

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.
• Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
• Alday E, Nieves JM, Planas A. Oxygen Reserve Index Predicts Hypoxemia During One-Lung Ventilation: An Observational Diagnostic Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):417-422. doi: 10.1053/j.jvca.2019.06.035. Epub 2019 Jun 28.
• Chen ST, Min S. Oxygen reserve index, a new method of monitoring oxygenation status: what do we need to know? Chin Med J (Engl). 2020 Jan 20;133(2):229-234. doi: 10.1097/CM9.0000000000000625.
• Campos JH, Sharma A. Predictors of Hypoxemia During One-Lung Ventilation in Thoracic Surgery: Is Oxygen Reserve Index (ORi) the Answer? J Cardiothorac Vasc Anesth. 2020 Feb;34(2):423-425. doi: 10.1053/j.jvca.2019.08.017. Epub 2019 Aug 18.
• Koishi W, Kumagai M, Ogawa S, Hongo S, Suzuki K. Monitoring the Oxygen Reserve Index can contribute to the early detection of deterioration in blood oxygenation during one-lung ventilation. Minerva Anestesiol. 2018 Sep;84(9):1063-1069. doi: 10.23736/S0375-9393.18.12622-8. Epub 2018 May 14.
• Sagiroglu G, Baysal A, Karamustafaoglu YA. The use of oxygen reserve index in one-lung ventilation and its impact on peripheral oxygen saturation, perfusion index and, pleth variability index. BMC Anesthesiol. 2021 Dec 20;21(1):319. doi: 10.1186/s12871-021-01539-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ventilation; one-lung ventilation; oxygen; perfusion; hypoxemia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: TrakyaH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study.
• IPD Sharing Time Frame: The data will be available after the publication of our data upon request from the researchers.
• IPD Sharing Access Criteria: There is no internet website to obtain data but the researchers can contact Dr. Gonul Sagiroglu or Dr. Ayse Baysal.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No