Ultrasonographic Assessment of Airway Edema Induced by Intra-abdominal Pressure During Laparoscopic Cholecystectomy: A Prospective, Double-Blind, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound
研究概览
简要总结
This prospective, double-blind, randomized clinical trial aims to investigate the development of airway edema associated with intra-abdominal pressure during laparoscopic cholecystectomy. A total of 66 adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned into two equal groups (33 patients per group) based on intra-abdominal pressure levels: low-pressure and standard-pressure pneumoperitoneum. Ultrasonographic measurements will be used to assess airway soft tissue thickness at predefined time points before and after the pneumoperitoneum. The primary objective is to determine whether increased intra-abdominal pressure contributes to postoperative airway edema, which may pose a risk during extubation.
详细描述
Airway edema can lead to difficult extubation and perioperative complications. Pneumoperitoneum during laparoscopic surgery increases intra-abdominal pressure (IAP), which may contribute to airway soft tissue edema due to cephalad fluid shifts and venous congestion. This prospective, randomized, double-blind study aims to assess whether different levels of IAP have a measurable effect on airway soft tissue thickness.
Patients aged 18 to 65 years, classified as ASA I-II, and scheduled for elective laparoscopic cholecystectomy will be included in the study. Upon arrival in the operating room, standard monitoring will be applied, anesthesia will be induced using intravenous sedation, and endotracheal intubation will be performed.
In the preoperative period, airway ultrasonography will be used to measure tongue thickness, midsagittal tongue cross-sectional area, tongue width, lateral pharyngeal wall thickness, parapharyngeal area thickness, and submental area thickness.
Patients will be randomly assigned into two groups:
Group 1: Patients receiving 10 mmHg intra-abdominal pressure Group 2: Patients receiving 14 mmHg intra-abdominal pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age between 18 and 65 years
- •ASA physical status I-II
- •Body mass index (BMI) < 30 kg/m²
- •Mallampati score I-II
- •Scheduled for elective laparoscopic cholecystectomy
排除标准
- •History of difficult intubation
- •Upper respiratory tract infection
- •Obstructive sleep apnea or STOP-Bang score ≥3
- •Severe cardiopulmonary disease
- •Pregnancy
- •Indication for emergency surgery
研究组 & 干预措施
10 mmHg Pneumoperitoneum
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg.
干预措施: 10 mmHg Pneumoperitoneum (Diagnostic Test)
14 mmHg Pneumoperitoneum
Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.
干预措施: 14 mmHg Pneumoperitoneum (Diagnostic Test)
结局指标
主要结局
Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound
时间窗: T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation
To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of airway edema will be assessed by measuring changes in lateral pharyngeal wall thickness using ultrasound before and after the procedure.
次要结局
- ultrasonographic airway parameter -tongue width(T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation)
- ultrasonographic airway parameter -tongue volume(T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation)
- ultrasonographic airway parameter-pharyngeal thickness(T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation)
- ultrasonographic airway parameter- neck circumference(T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation)
- oxygen saturation changes(Immediately after extubation and during early recovery (within the first 2 hours postoperative))
- hoarseness(Immediately after extubation and during early recovery (within the first 2 hours postoperative))
- stridor(Immediately after extubation and during early recovery (within the first 2 hours postoperative))
- re-intubation(Immediately after extubation and during early recovery (within the first 2 hours postoperative))
- sore throat(Immediately after extubation and during early recovery (within the first 2 hours postoperative))
- Correlation Between Intravenous Fluid Volume and Airway Edema(T0: Before intubation T1: After intubation T2: 30 minutes after the initiation of pneumoperitoneum T3: 5 minutes after extubation T4: 1 hour after extubation T5: 2 hours after extubation)
研究者
Engin Çetin
Principal Investigator
Kocaeli City Hospital