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

One-Lung Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050552
• Other study ID #: TrakyaH
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: September 2021
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxemia During Surgery
• Hypoxia
• One-Lung Ventilation
• Oxygen Reserve Index
• Perfusion Index
• Pleth Variability Index

Intervention

Device:
• Masimo Radical-7 Pulse CO-Oximeter
The Masimo Radical-7 Pulse CO-Oximeter is a device for the measurement of pulse oximetry, oxygen reserve index (ORi), perfusion index (PI), and pleth variability index (PVI). The device is the product of a company called Masimo Inc, Irvine, CA, USA

Locations

Country	Name	City	State
Turkey	Trakya University Training and Research Hospital	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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	Secondary Outcome-(2)	The Patients' demographic parameters and co-morbid diseases	Twenty-four hours prior to elective thoracic surgery operation
Secondary	Secondary Outcome-(3)	Measurement of mean arterial pressure (MAP)	During elective thoracic surgery every five minutes continuously
Secondary	Secondary Outcome-(4)	Measurement of systolic blood pressure (SBP)	During elective thoracic surgery every five minutes continuously
Secondary	Secondary Outcome-(5)	Measurement of diastolic blood pressure (DBP)	During elective thoracic surgery every five minutes continuously
Secondary	Secondary Outcome-(6)	Measurement of heart rate (HR)	During elective thoracic surgery every five minutes continuously
Secondary	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