Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256029
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-04
Brief Title:
Recruitment Maneuver in General Anesthesia for Laparoscopic Cholecystectomy
Sponsor:
University of Novi Sad
Organization:
University of Novi Sad
Study Overview
Official Title:
The Effect of Recruitment Maneuver on Static Compliance in Patients Undergoing General Anesthesia for Laparoscopic Cholecystectomy
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This is a prospective non-randomized clinical trial evaluating the effect of the recruitment maneuver on static compliance in patients undergoing general anesthesia for laparoscopic cholecystectomy
Detailed Description:
The study will be performed in patients who are scheduled for laparoscopic cholecystectomy They will be divided into two groups Group I will consist of non-obese patients Body Mass Index - BMI from 185 to 249 kgm² while group II will consist of patients with increased body mass pre-obese and obese class I with BMI from 25 to 349 kgm²
The recruitment maneuver will be performed by increasing the current peak pressure Ppeak by 5 cm H2O changing the inspiratoryexpiratory ratio from 12 to 11 with PEEP values of 5 and 7 cm H2O The respiratory rate during the recruitment maneuver will be 10 breaths per minute and the recruitment maneuver will last 30 seconds 5 breaths In both groups of patients the recruitment maneuver will be performed 3 times the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O the second time with a PEEP of 7 cm H2O during the duration of the operation The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure and immediately before the patient wakes up After each increase PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O
Parameters of respiratory mechanics and vital parameters will be monitored during multiple stages of the laparoscopic cholecystectomy as well as after the recruitment maneuver T1 after induction of anesthesia and before the formation of pneumoperitoneum T2 after the formation of pneumoperitoneum and positioning of the patient in reverse Trendelenburg position T3 after recruitment maneuver with PEEP values of 5 cm H2O T4 after recruitment maneuver with PEEP values of 7 cm H2O T5 after deflation T6 immediately before awakening with recruitment maneuver and PEEP values of 7 cm H2O All measurements will be made in VCV mode of mechanical ventilation and recruitment maneuver will be performed in pressure control ventilation PCV mode of mechanical lung ventilation
The parameters of the respiratory system mechanics will include Ppeak Pplat Plateau pressure Cdin Dynamic Compliance Cstat Static Compliance and DP Driving pressure The measurements will be taken in dynamic conditions Ppeak and Cdin and by using the maneuver of extending the inspiratory pause to 40 of the length of inspiration in static conditions Pplat and Cstat values will be obtained DP will be calculated according to the formula DP Pplat - PEEP
From the hemodynamic measurements changes in mean arterial pressure MAP and heart rate HR in the mentioned 6 time points T1 - T6 will be monitored Arterial blood gas analyzes will be sampled 2 times during the surgical procedure before the first recruitment maneuver and after the second recruitment maneuver
The recruitment maneuver will be performed by increasing the current peak pressure Ppeak by 5 cm H2O changing the inspiratoryexpiratory ratio from 12 to 11 with PEEP values of 5 and 7 cm H2O The respiratory rate during the recruitment maneuver will be 10 breaths per minute and the recruitment maneuver will last 30 seconds 5 breaths In both groups of patients the recruitment maneuver will be performed 3 times the first time immediately after the formation of the pneumoperitoneum and the positioning of the patient in the reverse Trendelenburg position with a PEEP of 5 cm H2O the second time with a PEEP of 7 cm H2O during the duration of the operation The third recruitment maneuver will be performed with a PEEP of 7 cm H2O at the end of the operative procedure and immediately before the patient wakes up After each increase PEEP will be maintained at higher pressure values with a peak value of 7 cm H2O
Parameters of respiratory mechanics and vital parameters will be monitored during multiple stages of the laparoscopic cholecystectomy as well as after the recruitment maneuver T1 after induction of anesthesia and before the formation of pneumoperitoneum T2 after the formation of pneumoperitoneum and positioning of the patient in reverse Trendelenburg position T3 after recruitment maneuver with PEEP values of 5 cm H2O T4 after recruitment maneuver with PEEP values of 7 cm H2O T5 after deflation T6 immediately before awakening with recruitment maneuver and PEEP values of 7 cm H2O All measurements will be made in VCV mode of mechanical ventilation and recruitment maneuver will be performed in pressure control ventilation PCV mode of mechanical lung ventilation
The parameters of the respiratory system mechanics will include Ppeak Pplat Plateau pressure Cdin Dynamic Compliance Cstat Static Compliance and DP Driving pressure The measurements will be taken in dynamic conditions Ppeak and Cdin and by using the maneuver of extending the inspiratory pause to 40 of the length of inspiration in static conditions Pplat and Cstat values will be obtained DP will be calculated according to the formula DP Pplat - PEEP
From the hemodynamic measurements changes in mean arterial pressure MAP and heart rate HR in the mentioned 6 time points T1 - T6 will be monitored Arterial blood gas analyzes will be sampled 2 times during the surgical procedure before the first recruitment maneuver and after the second recruitment maneuver
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