One-Lung VentilationNCT05050552
Oxygen Reserve Index in One-Lung Ventilation During Elective Thoracic Operations
An observational study of One-Lung Ventilation and Hypoxemia During Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- One-Lung Ventilation, Hypoxemia During Surgery, Oxygen Reserve Index
- What is being tested?
- Masimo Radical-7 Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 15 Aug 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal to participate in a study,
- History of severe asthma,
- Severe renal and hepatic insufficiencies,
- Pregnancy,
- History of previous pulmonary resection,
- Hemoglobinopathies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Training and Research Hospital
Edirne, 22030
About this study
Official title: 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.
Read the 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.
- Conditions
- One-Lung Ventilation, Hypoxemia During Surgery, Oxygen Reserve Index, Perfusion Index, Pleth Variability Index
- Being tested
- Masimo Radical-7 Pulse CO-Oximeter
- Keywords
- ventilation, hypoxemia, one-lung ventilation, oxygen, perfusion
- Medical subject headings
- Respiratory Aspiration, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7 Pulse CO-OximeterDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Outcome Measure-(1)
Baseline time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Thirteenth time point during thoracic operation defined as; at 90 minute after OLV placement during elective thoracic operation.
Secondary outcomes (7)
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)
Measured: During anesthesia induction and maintenance of elective thoracic operation
Secondary Outcome-(2)
The Patients' demographic parameters and co-morbid diseases
Measured: Twenty-four hours prior to elective thoracic surgery operation
Secondary Outcome-(3)
Measurement of mean arterial pressure (MAP)
Measured: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(4)
Measurement of systolic blood pressure (SBP)
Measured: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(5)
Measurement of diastolic blood pressure (DBP)
Measured: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(6)
Measurement of heart rate (HR)
Measured: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(7)
Arterial blood gas analysis during elective thoracic surgical operation
Measured: Five minutes after placing the patient in a lateral position with two-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Mar 2020
- Primary completion15 Jul 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for One-Lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Gonul Sagiroglu, Trakya University
- Investigators
- Hasan Umit, MD, Study chair, Trakya University, Trakya University Training and Research Hospital, Edirne, Turkey, 22030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050552
- Sponsor's protocol ID
- TrakyaH
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study.
Publications
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.
PubMed 19417615Applegate 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.
PubMed 27007078Alday 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.
PubMed 31362907Chen 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.
PubMed 31904726Campos 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.
PubMed 31500971Koishi 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.
PubMed 29756744Sagiroglu 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.
PubMed 34930139
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Reserve Index and Its Relations With Primary Hemodynamical and Oximeter Parameters During Elective Thoracic Surgical Operations
- ClinicalTrials.gov ID
- NCT05050552
- Acronym / sponsor ID
- TrakyaH
- Conditions
- One-Lung Ventilation, Hypoxemia During Surgery, Oxygen Reserve Index, Perfusion Index, Pleth Variability Index
- Keywords
- ventilation, hypoxemia, one-lung ventilation, oxygen, perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Refusal to participate in a study,
- History of severe asthma,
- Severe renal and hepatic insufficiencies,
- Pregnancy,
- History of previous pulmonary resection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Radical-7 Pulse CO-OximeterThe 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 | Device | – |
Primary outcome
Main Outcome Measure-(1)
Time frame: Baseline time point after patient's arrival into operating room before anesthesia induction during elective thoracic operation
Baseline time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(2)
Time frame: Preoxygenation time point before anesthesia induction during elective thoracic operation
Preoxygenatiom time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(3)
Time frame: 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
Third time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(4)
Time frame: 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
Fourth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(5)
Time frame: Fifth time point during thoracic operation defined as; at 1 minute after OLV placement during elective thoracic operation
Fifth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(6)
Time frame: Sixth time point during thoracic operation defined as; at 2 minute after OLV placement during elective thoracic operation.
Sixth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(7)
Time frame: Seventh time point during thoracic operation defined as; at 5 minute after OLV placement during elective thoracic operation.
Seventh time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(8)
Time frame: Eighth time point during thoracic operation defined as; at 10 minute after OLV placement during elective thoracic operation.
Eighth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(9)
Time frame: Ninth time point during thoracic operation defined as; at 15 minute after OLV placement during elective thoracic operation.
Ninth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(10)
Time frame: Tenth time point during thoracic operation defined as; at 30 minute after OLV placement during elective thoracic operation.
Tenth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(11)
Time frame: Eleventh time point during thoracic operation defined as; at 45 minute after OLV placement during elective thoracic operation.
Eleventh time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(12)
Time frame: Twelfth time point during thoracic operation defined as; at 60 minute after OLV placement during elective thoracic operation.
Twelfth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
Main Outcome Measure-(13)
Time frame: Thirteenth time point during thoracic operation defined as; at 90 minute after OLV placement during elective thoracic operation.
Thirteenth time point measurement of oxygen reserve index (ORi) equals to zero for predicting hypoxemia during one-lung ventilation
7 secondary outcomes
Secondary Outcome-(1)
Time frame: During anesthesia induction and maintenance of elective thoracic operation
Secondary Outcome-(2)
Time frame: Twenty-four hours prior to elective thoracic surgery operation
Secondary Outcome-(3)
Time frame: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(4)
Time frame: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(5)
Time frame: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(6)
Time frame: During elective thoracic surgery every five minutes continuously
Secondary Outcome-(7)
Time frame: Five minutes after placing the patient in a lateral position with two-lung ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Background: PubMed 19417615Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
- Background: PubMed 27007078Applegate 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.
- Results publication: PubMed 31362907Alday 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.
- Results publication: PubMed 31904726Chen 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.
- Results publication: PubMed 31500971Campos 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.
- Results publication: PubMed 29756744Koishi 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.
- Derived from this study: PubMed 34930139Sagiroglu 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.
- Individual participant dataSharing planned: Yes. Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Umit, MD study chair
Trakya University, Trakya University Training and Research Hospital, Edirne, Turkey, 22030
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of One-Lung Ventilation and Hypoxemia During Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Outcome Measure-(1) (time frame: Baseline time point after patient's arrival into operating room before anesthesia induction during elective thoracic operation). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050552, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.