跳至主要内容
临床试验/NCT06247943
NCT06247943已完成不适用

Lung Protective Ventilation Strategies to Improve Oxygenation Function and Respiratory Mechanics in Patients Undergoing Robotic Bariatric Surgery

Tianjin Medical University General Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024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
已完成
入组人数
42
试验地点
1
主要终点
Respiratory mechanics

研究概览

简要总结

Obesity is becoming a common condition and bariatric metabolic surgery is one of the main options for treating morbid obesity. However, since most patients undergoing robotic bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia management. Here, we explored the effects of lung-protective ventilation strategies on pulmonary oxygenation function and respiratory mechanics in patients undergoing robotic bariatric surgery.

详细描述

Forty obese patients who underwent robotic bariatric surgery in our hospital were selected and randomly divided into a lung-protective ventilation strategy group (Group P) and a control group (Group C). The volume-controlled mode was used to assist ventilation, and the inspiratory/expiratory ratio (I: E) was 1:2. Tidal volume (VT) was set according to the Predicted body weight (PBW) throughout the whole procedure, and in group C, VT was 9 ml /kg without Positive end-expiratory pressure (PEEP), and the inhaled oxygen concentration (Fraction of oxygen) was 0.5 ml /kg, while the inspiratory oxygen concentration (Fraction of oxygen) was 0.5 ml /kg. Group C: VT 9ml /kg, no Positive end-expiratory pressure (PEEP), Fraction of inspiration O2 (FiO2) of 60%; Group P: the ventilation mode was the same as that of Group C from tracheal intubation to the beginning of pneumoperitoneum for 10 minutes, and after 10 minutes of pneumoperitoneum, the ventilation mode was the same as that of Group C. After the pneumoperitoneum for 10 minutes, the ventilation mode was VT 7ml/kg, PEEP 6cmH2O, FiO2 of 40%, and the plateau pressure was maintained at <30cmH2O. In both groups, the intraoperative gas flow was 2L/min, and SpO2 was maintained at ≥95%; if it could not be maintained, the oxygenation function of the patients could be improved by adjusting the ventilation parameters and strategies; meanwhile, the respiratory rate (RR) was adjusted to maintain the End-tidal carbon dioxide partial pressure (PETCO2) at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%, and the end-tidal carbon dioxide partial pressure (PETCO2) was maintained at ≥30%. The respiratory mechanical parameters: tidal volume, RR, airway peak pressure (PPeak), plateau pressure (PPeak), and plateau pressure (PPeak) were recorded at 5 minutes after tracheal intubation (T0), 10 minutes after the start of the pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the pneumoperitoneum was closed (T4). pressure (PPeak), and plateau pressure (PPlate), and calculate the dynamic lung compliance; arterial blood was drawn at T0, T1, T2, T3, and T4, respectively, and the arterial partial pressure of oxygen (PaO2) and the arterial partial pressure of carbon dioxide (Arterial CO2) were measured. The arterial partial pressure of oxygen (PaO2) and arterial carbon dioxide pressure (PaCO2) were measured, and the oxygenation index (OI) was calculated.

研究设计

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

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Obese patients with ASA grade Ⅰ ~ Ⅲ No obvious abnormality in preoperative lung function and blood gas analysis results Undergoing robotic bariatric surgery

排除标准

  • •Had been mechanically ventilated 2 weeks before surgery Thoracic deformity Neuromuscular disease Significant abnormalities in vital organ function Combined pneumothorax or pulmonary herniation Participating in other clinical intervention trials or refusing general anesthesia with tracheal intubation Emergency surgery

研究组 & 干预措施

Control Group

Other

Use of general ventilation strategies

干预措施: regular ventilation (Procedure)

Lung Protective Ventilation Strategy Group

Experimental

Use of lung-protective ventilation strategies

干预措施: Lung Protective Ventilation Strategy (Procedure)

结局指标

主要结局

Respiratory mechanics

时间窗: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

plateau airway pressure

oxygenation

时间窗: 5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

Oxygenation index

次要结局

  • complications(postoperative days 1, 3, and 5)
  • Hemodynamics(5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guolin Wang

professor

Tianjin Medical University General Hospital

研究点 (1)

Loading locations...

相似试验