Ultrasound Assessment of Airway Edema During Laparoscopic Cholecystectomy

NCT ID: NCT07021482

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2025-09-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

10 mmHg Pneumoperitoneum

Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg.

Group Type: ACTIVE_COMPARATOR

10 mmHg Pneumoperitoneum

Intervention Type: DIAGNOSTIC_TEST

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

14 mmHg Pneumoperitoneum

Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.

Group Type: ACTIVE_COMPARATOR

14 mmHg Pneumoperitoneum

Intervention Type: DIAGNOSTIC_TEST

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• History of difficult intubation
• Upper respiratory tract infection
• Obstructive sleep apnea or STOP-Bang score ≥3
• Severe cardiopulmonary disease
• Pregnancy
• Indication for emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Engin Çetin

OTHER_GOV

Sponsor Role: lead

Responsible Party

Engin Çetin

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Aytac BG, Soyal OB. Ultrasonographic evaluation of the postoperative airway edema after robotic prostatectomy: a single center observational study. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8505-8513. doi: 10.26355/eurrev_202309_33775.

Reference Type: BACKGROUND

PMID: 37782166 (View on PubMed)

Other Identifiers

KSH-ANREA-EC-01

Identifier Type: -

Identifier Source: org_study_id