Recruitment Maneuver in General Anesthesia for Laparoscopic Cholecystectomy

The Effect of Recruitment Maneuver on Static Compliance in Patients Undergoing General Anesthesia for Laparoscopic Cholecystectomy

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

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Pressure High
• Intervention / Treatment: Procedure: Recruitment maneuver

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 18.5 to 24.9 kg/m²), while group II will consist of patients with increased body mass (pre-obese and obese class I with BMI from 25 to 34.9 kg/m²).

The recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, 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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada Andjelic, MD, PhD; Phone Number: +381214843484; Email: nada.andjelic@mf.uns.ac.rs

Study Locations

• Serbia
  • Novi Sad, Serbia, 21000
    • Recruiting
    • Clinical Center of Vojvodina
    • Contact: Nada Andjelic, MD, PhD; Phone Number: +381214843484; Email: nada.andjelic@mf.uns.ac.rs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients over 18 years of age
• ASA score ≤ 3 (American Society of Anesthesiologists Physical Status)
• scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

• patients under the age of 18
• pregnant women
• ASA status ˃ 3,
• BMI < 18.5, and ≥ 35 kg/m2
• previous open abdominal surgery
• previous lung surgery
• obstructive and restrictive lung diseases
• neuromuscular diseases
• hemodynamic instability during recruitment maneuver (drop in systolic blood pressure by more than 20% compared to basal values or systolic blood pressure < 90 mmHg)
• bradycardia (drop in heart rate by more than 20% or frequency < 50/min)
• decrease in saturation (SpO2 ≤ 92% for more than 1 minute) during the recruitment maneuver

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; All participants will undergo the recruitment maneuver. The patients will be divided into non-obese patients (BMI 18.5-24.9 kg/m²) and patients with increased body mass (BMI 25-34.9 kg/m²).

Procedure: Recruitment maneuver; The recruitment maneuver will be performed by increasing the current peak pressure (Ppeak) by 5 cm H2O, changing the inspiratory/expiratory ratio from 1:2 to 1:1, 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). 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static compliance	Cstat = VT / (Pplat - PEEP)	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	MAP = (SBP + 2*DBP) / 3	3 hours
Arterial blood oxygen level	Partial pressure of oxygen in arterial blood gas analysis	3 hours

Collaborators and Investigators

• Sponsor: University of Novi Sad

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 00-39/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No