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临床试验/NCT06994780
NCT06994780进行中(未招募)不适用

Lung Ultrasound Evaluation of the Effects of Positive End-Expiratory Pressure (PEEP) and Recruitment Strategies Adjusted for Intraoperative Dynamic Compliance on Postoperative Respiratory Complications in Obese Patients Planned for Laparoscopic Surgery

Marmara University Pendik Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
70
试验地点
2
主要终点
Modified lung ultrasound score

研究概览

简要总结

This study aims to investigate the effects of the personalized application of respiratory pressures applied to patients undergoing laparoscopic bariatric surgery when they are connected to a ventilator under general anesthesia, on the postoperative period. The effects of the ventilation practices that are fixed in routine practice and revised according to various variables during the surgery during artificial respiration after intubation under general anesthesia will be examined with ultrasonography. No change will be made to the routine anesthesia practice for this purpose, the pressure values in the ventilator under general anesthesia will be adjusted during the surgery within the framework of the values used in anesthesia practice. After the surgery, the lung area will be examined with ultrasound in the recovery unit and the findings will be recorded. This study does not have any undesirable effects or risks. This study does not include any interventional procedures.

详细描述

Our study is a double-blind study and the specialist physician performing the postoperative lung ultrasound will not know which group the patient is in. Before the patients are taken into surgery, they will be determined by a permanent anesthesiologist in the preoperative evaluation room using the closed envelope method. The teams that perform all measurements and randomize the patients will remain constant throughout the study. Patients who agree to participate in the study will undergo standard monitoring (heart rate - HR, peripheral oxygen saturation - SpO2, noninvasive blood pressure - NIBP, end-tidal carbon dioxide pressure - etCO2) followed by anesthesia induction. After endotracheal intubation, patients will begin to breathe with volume-controlled ventilation-VCV mode.

In the first group (group PEEP8), a tidal volume of 6-8 ml/kg will be adjusted according to their ideal weight and a fixed PEEP of 8cmH20 will be applied throughout the intraoperative period, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated. The second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While applying PEEP titration to patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals so that the maximum peak pressure is 45 cmH2O and the driving pressure is 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained. The spO2 values of the patients in both groups will be targeted as 92-94%, the EtCO2 values as 35-45 cmH2O, and the FiO2 and respiratory rate will be adjusted accordingly. After extubation, the patient will be taken to the recovery room and monitored. After 15 minutes, lung ultrasound (USG) will be performed on patients in both groups by an experienced anesthesiologist who is blinded to the study using the MyLab ™ Seven convex probe (2-5 MHz). Both hemithoraxes will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated for lung sliding movement, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated using the modified lung ultrasound score will be recorded and compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

this study is a double-blind study. the patient and the specialist physician performing the postoperative lung ultrasound will not know which group the patient is in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients over the age of 18, with a body mass index of 35 and above, and who are scheduled for laparoscopic bariatric surgery will be included in our study.

排除标准

  • •Patients with advanced COPD,
  • •Patients with a history of pneumothorax,
  • •Patients with lung bullae,
  • •Patients who have undergone thoracic surgery,
  • •Patients with a diagnosis of major cardiac disease (valve diseases, heart failure, systolic dysfunction),
  • •Patients with severe respiratory failure,
  • •Patients with previous pulmonary surgery will not be included in the study.

研究组 & 干预措施

group PEEP8

No Intervention

The first group (group PEEP8) will be applied with a fixed PEEP of 8cmH20 throughout the intraoperative period by adjusting the tidal volume of 6-8 ml/kg according to the ideal weight, and a manual recruitment maneuver (with a pressure of 30 cmH2O for 40 seconds) will be applied after the pneumoperitoneum is terminated.

group DC

Experimental

The second group (Group DC) will be ventilated in VCV mode again and a tidal volume of 6-8 ml/kg will be given according to their ideal weight. The PEEP value at which the highest compliance value determined in the anesthesia device is obtained will be adjusted. In this group, PEEP titration will be repeated during pneumoperitoneum and skin closure. While PEEP titration is applied to the patients, a recruitment maneuver will also be applied. In this maneuver, PEEP will be increased at 2-minute intervals with a maximum peak pressure of 45 cmH2O and a driving pressure of 15 cmH2O, and when the target is reached, it will be decreased and the PEEP value will be adjusted at the value at which the highest compliance is obtained.

干预措施: dynamic compliance guided PEEP titration (Procedure)

结局指标

主要结局

Modified lung ultrasound score

时间窗: At the end of the surgery, a modified lung ultrasonography will be performed in the recovery unit.

Each hemithorax will be divided into 6 regions by 3 vertical lines from the anterior axillary, parasternal and posterior axillary lines; 2 horizontal imaginary lines 1 cm above the nipple and at the level of the diaphragm. Each region will be evaluated in terms of lung sliding motion, A lines, B lines, consolidation, air bronchograms, pleural effusion and pneumothorax, and the total score calculated for 12 regions will be recorded and compared using the scoring system defined by Monastesse et al (2017).

次要结局

  • postoperative pulmonary complications(postoperative 3 days)
  • hospitalization day(postoperative day 1-8)
  • postoperatif blood result(postoperative day 1 to 8)

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

dilara gocmen

Dilara Göçmen, Department of Anesthesiology and Reanimation

Marmara University Pendik Training and Research Hospital

研究点 (2)

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