Evaluation of the Effects of Fresh Gas Flow Differences on the Lungs Using Ultrasonography in Laparoscopic Cholecystectomy Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Lung Ultrasound Score
研究概览
简要总结
This prospective randomized clinical trial aims to evaluate the effects of different fresh gas flow rates on postoperative pulmonary aeration using lung ultrasonography in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomly assigned to receive either low-flow anesthesia (0.5 L/min) or high-flow anesthesia (4 L/min) during maintenance of general anesthesia. The primary objective is to compare postoperative lung ultrasound scores and the incidence of atelectasis between the two groups.
详细描述
Pulmonary atelectasis is one of the most common postoperative pulmonary complications following general anesthesia. Fresh gas flow is an important component of inhalational anesthesia and may influence airway humidity, gas exchange, respiratory mechanics, and pulmonary physiology. Although low-flow anesthesia has recognized economic, environmental, and physiological advantages, the effect of different fresh gas flow rates on postoperative lung aeration has not been adequately investigated.
This prospective, randomized, parallel-group clinical trial will be conducted at Adıyaman University Training and Research Hospital. Adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly allocated to either a low-flow group (0.5 L/min) or a high-flow group (4 L/min) after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation. Standardized anesthesia management will be applied to all participants.
Postoperative lung ultrasonography will be performed 30 minutes after extubation in the post-anesthesia care unit. Lung Ultrasound Score (LUS) and the incidence of postoperative atelectasis will be compared between the study groups. The findings are expected to provide evidence regarding the effects of different fresh gas flow strategies on postoperative pulmonary outcomes and may contribute to optimizing intraoperative anesthesia management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
- •Able and willing to provide written informed consent.
排除标准
- •Refusal to participate in the study.
- •History of chronic respiratory disease, including severe asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.
- •History of alcohol or substance abuse.
- •Intraoperative airway or respiratory complications during endotracheal intubation or surgery.
- •Life-threatening postoperative complications.
- •Patients with ASA physical status III or higher.
研究组 & 干预措施
Low Fresh Gas Flow
Participants will receive general anesthesia with a fresh gas flow rate of 0.5 L/min during the maintenance phase following an initial fresh gas flow of 4 L/min for 8 minutes after endotracheal intubation. Postoperative lung ultrasonography will be performed 30 minutes after extubation.
干预措施: Low Fresh Gas Flow (0.5 L/min) (Procedure)
High Fresh Gas Flow
Participants will receive general anesthesia with a fresh gas flow rate of 4 L/min during the maintenance phase following an initial fresh gas flow of 4 L/min for 8 minutes after endotracheal intubation. Postoperative lung ultrasonography will be performed 30 minutes after extubation.
干预措施: High Fresh Gas Flow (4 L/min) (Procedure)
结局指标
主要结局
Postoperative Lung Ultrasound Score
时间窗: 30 minutes after extubation
Lung ultrasonography will be performed 30 minutes after extubation. Both lungs will be divided into 12 regions, with 6 regions assessed in each lung. Each region will be scored from 0 to 3: 0 indicates normal aeration with A-lines or fewer than three B-lines; 1 indicates at least three well-spaced B-lines; 2 indicates coalescent B-lines; and 3 indicates lung consolidation. The scores from all regions will be summed, resulting in a total score ranging from 0 to 36. Higher scores indicate greater loss of lung aeration.
次要结局
- Peak airway pressure(Throughout the intraoperative period)
- Incidence of postoperative atelectasis(30 minutes after extubation)
- Peripheral oxygen saturation (SpO₂)(During surgery)
- Mean arterial pressure(During surgery)
- Heart rate(During surgery)
研究者
MEHMET DURAN
Assistant Professor
Adiyaman University