One-Lung Ventilation Clinical Trial
Official title:
Oxygen Reserve Index and Its Relations With Primary Hemodynamical and Oximeter Parameters During Elective Thoracic Surgical Operations
NCT number | NCT05050552 |
Other study ID # | TrakyaH |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | August 15, 2021 |
Verified date | September 2021 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Trakya University Training and Research Hospital | Edirne |
Lead Sponsor | Collaborator |
---|---|
Trakya University |
Turkey,
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
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 |
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