Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540794
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Evaluating Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Robot-Assisted Laparoscopic Radical Prostatectomy is a method increasingly used for prostate cancer due to fewer complications morbidity and mortality compared to other methods The technique involves inflating the abdomen with carbon dioxide to provide visualization and working in a steep Trendelenburg position which puts pressure on the lungs and can cause them to collapse The functional residual capacity reduction caused by general anesthesia combined with the negative effects of the position increases the risk of significant respiratory system complications during and after surgery
Lung protective ventilation strategies can reduce the incidence of postoperative pulmonary complications PPC by alleviating iatrogenic injury to previously healthy lungs Apart from a low tidal volume VT applying positive end-expiratory pressure PEEP can minimize the risk of atelectasis andor overdistension
There is limited information on how to adjust optimal PEEP under increased intra-abdominal pressure during laparoscopy A meta-analysis study on acute respiratory distress syndrome ARDS patients showed that high driving pressure plateau pressure - PEEP is the most associated value with mortality It was shown that VT plateau pressure and PEEP are not related to patient outcomes or only when they affect driving pressure Subsequent retrospective and prospective studies confirmed the importance of driving pressure in ARDS patients and surgical patients
For patients under mechanical ventilation applying a personalized PEEP that provides the lowest driving pressure along with maneuvers to open closed alveoli recruitment reduces respiratory system complications during and after surgery One method to visualize the effects of these maneuvers and the ideal PEEP application which provides the lowest driving pressure for the patient is electrical impedance tomography EIT a non-invasive radiation-free bedside imaging technique
EIT measured with 16 electrodes placed on an elastic belt around the patientampamp39s 4th to 6th ribs shows impedance changes in the lungs This method successfully visualizes and evaluates dynamic changes in gas distribution within the lungs and has been validated by computed tomography scans proving safe for use in both adults and pediatric patients EIT divides the lungs into four layers from ventral to dorsal showing the percentage distribution of tidal volume in these regions Examining the relative impedance changes allows for observing gas volume distribution entering the lungs and evaluating regional lung characteristics
Therefore EIT can contribute to examining the PEEP value that ensures homogeneous gas distribution in the lungs and preventing ventilator-associated lung injury
The aim of our study is to evaluate the effect of driving pressure guided mechanical ventilation on lung gas distribution during robot-assisted laparoscopic radical prostatectomy through respiratory parameters recorded by EIT during surgery and perioperative period and to compare perioperative pulmonary complications with traditional ventilation methods
Lung protective ventilation strategies can reduce the incidence of postoperative pulmonary complications PPC by alleviating iatrogenic injury to previously healthy lungs Apart from a low tidal volume VT applying positive end-expiratory pressure PEEP can minimize the risk of atelectasis andor overdistension
There is limited information on how to adjust optimal PEEP under increased intra-abdominal pressure during laparoscopy A meta-analysis study on acute respiratory distress syndrome ARDS patients showed that high driving pressure plateau pressure - PEEP is the most associated value with mortality It was shown that VT plateau pressure and PEEP are not related to patient outcomes or only when they affect driving pressure Subsequent retrospective and prospective studies confirmed the importance of driving pressure in ARDS patients and surgical patients
For patients under mechanical ventilation applying a personalized PEEP that provides the lowest driving pressure along with maneuvers to open closed alveoli recruitment reduces respiratory system complications during and after surgery One method to visualize the effects of these maneuvers and the ideal PEEP application which provides the lowest driving pressure for the patient is electrical impedance tomography EIT a non-invasive radiation-free bedside imaging technique
EIT measured with 16 electrodes placed on an elastic belt around the patientampamp39s 4th to 6th ribs shows impedance changes in the lungs This method successfully visualizes and evaluates dynamic changes in gas distribution within the lungs and has been validated by computed tomography scans proving safe for use in both adults and pediatric patients EIT divides the lungs into four layers from ventral to dorsal showing the percentage distribution of tidal volume in these regions Examining the relative impedance changes allows for observing gas volume distribution entering the lungs and evaluating regional lung characteristics
Therefore EIT can contribute to examining the PEEP value that ensures homogeneous gas distribution in the lungs and preventing ventilator-associated lung injury
The aim of our study is to evaluate the effect of driving pressure guided mechanical ventilation on lung gas distribution during robot-assisted laparoscopic radical prostatectomy through respiratory parameters recorded by EIT during surgery and perioperative period and to compare perioperative pulmonary complications with traditional ventilation methods
Detailed Description:
General anesthesia increases the risk of respiratory complications and impairs arterial oxygenation by causing atelectasis in the dorsal regions of the lungs Postoperative pulmonary complications PPC represent events such as atelectasis pulmonary edema pneumonia pleuritis reintubation and the need for oxygen support after surgery and are associated with increased morbidity mortality intensive care and hospital stay durations as well as higher healthcare costs The effective strategy to reduce the incidence of PPC in patients under general anesthesia is still not clear
Robot-assisted surgeries are increasingly preferred for prostatectomy a curative treatment for prostate cancer due to advantages such as less blood loss less scar tissue formation and shorter hospital stays compared to other surgical methods During robotic surgery many factors such as laparoscopy pneumoperitoneum and extreme Trendelenburg position can negatively affect lung function Studies have shown that high driving pressure values resulting from the set tidal volume target and PEEP values during mechanical ventilation increase postoperative pulmonary complications
Developing mechanical ventilation strategies based on personalized PEEP values that provide the lowest driving pressure after recruitment maneuvers to include closed alveoli in respiration and monitoring the effects of this method on the lungs during the perioperative period using electrical impedance tomography EIT is a highly useful tool EIT a non-invasive radiation-free bedside monitoring system that detects real-time regional ventilation changes can be used to guide individualized protective ventilation strategies to reduce perioperative respiratory system complications Examining ROI values measured by EIT shows the effect of ventilation strategies on the distribution of tidal volume in the lungs ROIs calculated by selecting layers with ROI 1 and ROI 2 reflecting the ventral parts and ROI 3 and ROI 4 reflecting the dorsal parts can be used to demonstrate the effect of the chosen ventilation strategy on lung gas distribution through intergroup comparison
The age gender height weight body mass index diagnosis ASA score preoperative hemoglobin level additional systemic diseases smoking history prostate-specific antigen level Gleason score and prostate volume of the patients will be recorded All patients will be monitored with electrocardiogram ECG peripheral oxygen saturation SpO2 invasive arterial pressure systolic arterial pressure diastolic arterial pressure and mean arterial pressure and electrical impedance tomography Patients will be prospectively randomized into two groups group assignments will be determined using a closed-envelope technique
All patients will be preoxygenated with 80 FiO2 followed by induction of anesthesia with 2 mcgkg fentanyl 2 mgkg propofol and 06 mgkg rocuronium After orotracheal intubation patients will be placed on mechanical ventilation in volume control-autoflow mode with 8 mlkg tidal volume 2 Lmin fresh gas flow 04 inspired fractional oxygen FiO2 an inspiratory expiratory ratio of 12 and a respiratory rate to achieve normocapnia partial carbon dioxide pressure PaCO2 35-45 mmHg Recruitment maneuvers will be applied to all patients
During the recruitment maneuver with an inspiratory expiratory ratio of 11 a respiratory rate of 12 breathsmin ventilation with a tidal volume of 8 mlkg will be applied for 1 minute at a PEEP level of 5 cmH2O This will be followed by ventilation with a tidal volume of 10 mlkg for 1 minute at 10 cmH2O PEEP and finally ventilation with a tidal volume of 12 mlkg for 1 minute at 15 cmH2O PEEPThe mechanical ventilation strategies for the patients will be planned according to their group
For all patients systolic arterial pressure diastolic arterial pressure mean arterial pressure heart rate and SpO2 values will be recorded before induction after intubation at 5-minute intervals for up to 60 minutes after pneumoperitoneum and Trendelenburg position at 60 minutes after Trendelenburg position at 75 minutes after Trendelenburg position at 90 minutes after Trendelenburg position at 120 minutes after Trendelenburg position at 180 minutes after Trendelenburg position at 240 minutes after Trendelenburg position before extubation 5 minutes after extubation at 60 minutes postoperatively at 24 hours postoperatively and at 48 hours postoperatively Additionally while the patient is on mechanical ventilation peak pressure plateau pressure PEEP mean airway pressure MPaw compliance and end-tidal carbon dioxide values will also be recorded
Intermittent arterial blood gas analysis with invasive arterial monitoring is a routine practice in our daily practice Arterial blood gas analysis will be performed preoperatively immediately after intubation at 15 60 and 120 minutes after pneumoperitoneum and Trendelenburg position immediately before extubation and 5 minutes after extubation with pH partial oxygen pressure pO2 partial carbon dioxide pressure pCO2 oxygenation index pO2FiO2 bicarbonate lactate and hemoglobin values recorded
Anesthesia duration perioperative fluid volume perioperative blood loss and urine output operation duration pneumoperitoneum duration mechanical ventilation duration and vasoactive agent use duration will be recorded
In all patients ROI values measured by electrical impedance tomography which we use routinely in our daily practice will be recorded before intubation immediately after intubation at 15 60 and 120 minutes after pneumoperitoneum and Trendelenburg position immediately before extubation in the supine position and 5 minutes after extubation
Postoperative pulmonary complications in patients will be monitored using SpO2 fever cough and sputum history as well as prolonged intubation if present and the duration of oxygen support and the development of additional pathology will be recorded
Robot-assisted surgeries are increasingly preferred for prostatectomy a curative treatment for prostate cancer due to advantages such as less blood loss less scar tissue formation and shorter hospital stays compared to other surgical methods During robotic surgery many factors such as laparoscopy pneumoperitoneum and extreme Trendelenburg position can negatively affect lung function Studies have shown that high driving pressure values resulting from the set tidal volume target and PEEP values during mechanical ventilation increase postoperative pulmonary complications
Developing mechanical ventilation strategies based on personalized PEEP values that provide the lowest driving pressure after recruitment maneuvers to include closed alveoli in respiration and monitoring the effects of this method on the lungs during the perioperative period using electrical impedance tomography EIT is a highly useful tool EIT a non-invasive radiation-free bedside monitoring system that detects real-time regional ventilation changes can be used to guide individualized protective ventilation strategies to reduce perioperative respiratory system complications Examining ROI values measured by EIT shows the effect of ventilation strategies on the distribution of tidal volume in the lungs ROIs calculated by selecting layers with ROI 1 and ROI 2 reflecting the ventral parts and ROI 3 and ROI 4 reflecting the dorsal parts can be used to demonstrate the effect of the chosen ventilation strategy on lung gas distribution through intergroup comparison
The age gender height weight body mass index diagnosis ASA score preoperative hemoglobin level additional systemic diseases smoking history prostate-specific antigen level Gleason score and prostate volume of the patients will be recorded All patients will be monitored with electrocardiogram ECG peripheral oxygen saturation SpO2 invasive arterial pressure systolic arterial pressure diastolic arterial pressure and mean arterial pressure and electrical impedance tomography Patients will be prospectively randomized into two groups group assignments will be determined using a closed-envelope technique
All patients will be preoxygenated with 80 FiO2 followed by induction of anesthesia with 2 mcgkg fentanyl 2 mgkg propofol and 06 mgkg rocuronium After orotracheal intubation patients will be placed on mechanical ventilation in volume control-autoflow mode with 8 mlkg tidal volume 2 Lmin fresh gas flow 04 inspired fractional oxygen FiO2 an inspiratory expiratory ratio of 12 and a respiratory rate to achieve normocapnia partial carbon dioxide pressure PaCO2 35-45 mmHg Recruitment maneuvers will be applied to all patients
During the recruitment maneuver with an inspiratory expiratory ratio of 11 a respiratory rate of 12 breathsmin ventilation with a tidal volume of 8 mlkg will be applied for 1 minute at a PEEP level of 5 cmH2O This will be followed by ventilation with a tidal volume of 10 mlkg for 1 minute at 10 cmH2O PEEP and finally ventilation with a tidal volume of 12 mlkg for 1 minute at 15 cmH2O PEEPThe mechanical ventilation strategies for the patients will be planned according to their group
For all patients systolic arterial pressure diastolic arterial pressure mean arterial pressure heart rate and SpO2 values will be recorded before induction after intubation at 5-minute intervals for up to 60 minutes after pneumoperitoneum and Trendelenburg position at 60 minutes after Trendelenburg position at 75 minutes after Trendelenburg position at 90 minutes after Trendelenburg position at 120 minutes after Trendelenburg position at 180 minutes after Trendelenburg position at 240 minutes after Trendelenburg position before extubation 5 minutes after extubation at 60 minutes postoperatively at 24 hours postoperatively and at 48 hours postoperatively Additionally while the patient is on mechanical ventilation peak pressure plateau pressure PEEP mean airway pressure MPaw compliance and end-tidal carbon dioxide values will also be recorded
Intermittent arterial blood gas analysis with invasive arterial monitoring is a routine practice in our daily practice Arterial blood gas analysis will be performed preoperatively immediately after intubation at 15 60 and 120 minutes after pneumoperitoneum and Trendelenburg position immediately before extubation and 5 minutes after extubation with pH partial oxygen pressure pO2 partial carbon dioxide pressure pCO2 oxygenation index pO2FiO2 bicarbonate lactate and hemoglobin values recorded
Anesthesia duration perioperative fluid volume perioperative blood loss and urine output operation duration pneumoperitoneum duration mechanical ventilation duration and vasoactive agent use duration will be recorded
In all patients ROI values measured by electrical impedance tomography which we use routinely in our daily practice will be recorded before intubation immediately after intubation at 15 60 and 120 minutes after pneumoperitoneum and Trendelenburg position immediately before extubation in the supine position and 5 minutes after extubation
Postoperative pulmonary complications in patients will be monitored using SpO2 fever cough and sputum history as well as prolonged intubation if present and the duration of oxygen support and the development of additional pathology will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None