Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481124
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-18
Brief Title:
End-expiratory Pressure During Laparoscopic Surgery in the Trendelenburg Position by Electrical Impedance Tomography
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery in the Trendelenburg Position Based on Ventilation and Perfusion Measured by Electrical Impedance Tomography the CP-EIT Observational Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
CP-EIT
Brief Summary:
Pneumoperitoneum PNP and the position of the patient required for laparoscopic surgery lead to pathophysiological changes that complicate anesthesia PNP is characterized by an increased intra-abdominal pressure IAP the cranial displacement of the diaphragm that can lead to the formation of intraoperative atelectasis and decrease end-expiratory lung volume EELV At the same time PNP can reduce respiratory system compliance by 30-50 in healthy patients During elective abdominal surgery under general anesthesia atelectasis forms in almost 90 of patients and can become a focus of postoperative pneumonia The negative effect of PNP is more prominent in Trendelenburg position And one of the methods to avoid the effects of PNP and Trendelenburg position on lung tissue is to apply positive end-expiratory pressure PEEP PEEP is acknowledged as a component of lung protective ventilation LPV along with low tidal volume TV 6-8 mlkg On the other hand excessive PEEP can lead to the overdistension of lung tissue and cause volutrauma and hemodynamic instability It is necessary to use sufficient PEEP to minimize atelectasis improve respiratory biomechanics and maintain oxygenation
Electrical impedance tomography shows changes in ventilation and perfusion during mechanical ventilation with the different PEEP levels
The study aimed to select optimum PEEP level based on optimum ventilation-to-perfusion match based on electrical impedance tomography measurements
Electrical impedance tomography shows changes in ventilation and perfusion during mechanical ventilation with the different PEEP levels
The study aimed to select optimum PEEP level based on optimum ventilation-to-perfusion match based on electrical impedance tomography measurements
Detailed Description:
Electrical impedance tomography shows changes in ventilation and perfusion during mechanical ventilation with the different PEEP levels The investigators will measure the following variables resistivity of low and high pass band and end-expiratory lung index in 4 regions of interest and globally global inhomogeneity index global lung-heart index global regional ventilation delay compliance win compliance loss plateau pressure and driving pressure
The investigators will measure abovementioned variables in the following conditions
PEEP 5 mbar with the patient in a horizontal supine position initial measurement Baseline
PEEP 5 mbar in Trendelenburg position in carboxyperitoneum conditions after reaching the set abdominal pressure of 12-14 mbar reference measurement Ref
PEEP 8 mbar in Trendelenburg position under carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 10 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 12 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 14 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 16 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 5 mbar with the patient in a horizontal supine position after deflation of the carboxyperitoneum
After 5 minutes of carboxyperitoneum in Trendelenburg position the investigators will assess ventilation perfusion and their relationship by the Analysis tab in comparison with the initial one in the intubated patient in the supine position Baseline improvement of ventilation CW - compliance win in and deterioration of ventilation CL - compliance loss in global homogeneity of ventilation GI - homogeneity index in regional ventilation delays RVD in ventilation compliance index and perfusion LHI - lung heart index in
After all stages have been completed a comparative analysis of the influence of different levels of PEEP on ventilation perfusion and their ratio will be carried out by using the Analysis tab at each stage in comparison with the reference Ref CW and CL GI RVD LHI
The investigators will measure abovementioned variables in the following conditions
PEEP 5 mbar with the patient in a horizontal supine position initial measurement Baseline
PEEP 5 mbar in Trendelenburg position in carboxyperitoneum conditions after reaching the set abdominal pressure of 12-14 mbar reference measurement Ref
PEEP 8 mbar in Trendelenburg position under carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 10 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 12 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 14 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 16 mbar in Trendelenburg position in carboxyperitoneum conditions abdominal pressure 12-14 mbar
PEEP 5 mbar with the patient in a horizontal supine position after deflation of the carboxyperitoneum
After 5 minutes of carboxyperitoneum in Trendelenburg position the investigators will assess ventilation perfusion and their relationship by the Analysis tab in comparison with the initial one in the intubated patient in the supine position Baseline improvement of ventilation CW - compliance win in and deterioration of ventilation CL - compliance loss in global homogeneity of ventilation GI - homogeneity index in regional ventilation delays RVD in ventilation compliance index and perfusion LHI - lung heart index in
After all stages have been completed a comparative analysis of the influence of different levels of PEEP on ventilation perfusion and their ratio will be carried out by using the Analysis tab at each stage in comparison with the reference Ref CW and CL GI RVD LHI
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