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

NCT05050552 | Completed

• 1 other identifier: TrakyaH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ventilation; hypoxemia; one-lung ventilation; oxygen; perfusion

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (7)

• Secondary Outcome-(1)

  During anesthesia induction and maintenance of elective thoracic operation

• Secondary Outcome-(2)

  Twenty-four hours prior to elective thoracic surgery operation

• Secondary Outcome-(3)

  During elective thoracic surgery every five minutes continuously

• Secondary Outcome-(4)

  During elective thoracic surgery every five minutes continuously

• Secondary Outcome-(5)

  During elective thoracic surgery every five minutes continuously

Interventions

Masimo Radical-7 Pulse CO-Oximeter DEVICE

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

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Training and Research Hospital

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 19417615 BACKGROUND

• 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

• 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.

  PMID: 31362907 RESULT

• 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.

  PMID: 31904726 RESULT

• 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. No abstract available.

  PMID: 31500971 RESULT

• 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.

  PMID: 29756744 RESULT

• 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.

  PMID: 34930139 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Hasan Umit, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 20, 2021
• Study Start: March 1, 2020
• Primary Completion: July 15, 2021
• Study Completion: August 15, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available after the publication of our data upon request from the researchers.
• Access Criteria: There is no internet website to obtain data but the researchers can contact Dr. Gonul Sagiroglu or Dr. Ayse Baysal.

Locations

TU (1)