NCT07021482

Ultrasound Assessment of Airway Edema During Laparoscopic Cholecystectomy

Ultrasonographic Assessment of Airway Edema Induced by Intra-abdominal Pressure During Laparoscopic Cholecystectomy: A Prospective, Double-Blind, Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Engin Çetin · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 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

Conditions

• Airway Edema
• Perioperative Complication
• Pneumoperitoneum

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	10 mmHg Pneumoperitoneum	Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.
DIAGNOSTIC_TEST	14 mmHg Pneumoperitoneum	Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

Timeline

• Start date: 2025-06-18
• Primary completion: 2025-09-17
• Completion: 2025-09-17
• First posted: 2025-06-15
• Last updated: 2025-11-18

Locations

1 site across 1 country: Turkey (Türkiye)