Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05050552
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2021-09-06
Brief Title:
Oxygen Reserve Index in One-Lung Ventilation During Elective Thoracic Operations
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
Oxygen Reserve Index and Its Relations With Primary Hemodynamical and Oximeter Parameters During Elective Thoracic Surgical Operations
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 clinicaltrialsgov 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 mgkg rocuronium Esmeron Organon Pharmaceuticals USA at a dose of 06 mgkg and fentanyl Janssen fentanyl Janssen Pharmaceutical Belgium at a dose of 2 to 3 mcgkg 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 02 mcgkg 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 FiO2value 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 literminute 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
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 clinicaltrialsgov 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 mgkg rocuronium Esmeron Organon Pharmaceuticals USA at a dose of 06 mgkg and fentanyl Janssen fentanyl Janssen Pharmaceutical Belgium at a dose of 2 to 3 mcgkg 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 02 mcgkg 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 FiO2value 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 literminute 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None