Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Mechanical Ventilation Pressure High

NCT number NCT06256029
Study type Interventional
Source University of Novi Sad
Contact Nada Andjelic, MD, PhD
Phone +381214843484
Email nada.andjelic@mf.uns.ac.rs
Status Recruiting
Phase N/A
Start date February 1, 2023
Completion date September 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT02506270 - Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy N/A
Not yet recruiting NCT05341687 - Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
Recruiting NCT06168162 - Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics N/A
Completed NCT03721237 - Esophageal Balloon Calibration in Assisted Ventilation Mode N/A
Not yet recruiting NCT03854565 - Glycocalyx Biomarkers in ARDS for Clinical Prognosis and Pulmonary Fibrosis
Completed NCT04359251 - Different PEEP Settings of COVID-19 Induced ARDS N/A
Not yet recruiting NCT06232915 - Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation
Completed NCT03589482 - Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure N/A
Recruiting NCT05902403 - Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure
Completed NCT03111303 - Mechanical Ventilation Parameters in HAP Patients N/A
Recruiting NCT05098717 - End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
Recruiting NCT05554536 - Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery N/A
Completed NCT02993887 - Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children N/A
Recruiting NCT03868982 - Lung Protection in ARDS Using Neurally Adjusted Ventilatory Assist N/A
Recruiting NCT04924920 - Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation N/A
Completed NCT04723043 - The Effect of Ventilation Modes on Cerebral Oxymetry In Operation N/A
Recruiting NCT06229886 - Effect of PEEP on TRJV in Mechanically Intubated Pediatric Patients N/A
Recruiting NCT05150847 - Prone Positioning in COVID-19 Patients N/A
Withdrawn NCT06093958 - Paradoxical Response to Chest Wall Loading in Mechanically Ventilated Patients N/A
Recruiting NCT05440851 - Platform of Randomized Adaptive Clinical Trials in Critical Illness N/A