Ultrasound Assessment of Airway Edema During Laparoscopic Cholecystectomy

NCT07021482 | Completed

• 1 other identifier: KSH-ANREA-EC-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Edema; Perioperative Complication; Pneumoperitoneum

Keywords

Airway Ultrasound; Upper Airway Edema; Pneumoperitoneum; Intra-abdominal Pressure

Outcome Measures

Primary Outcomes (1)

• Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound

  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.

  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

Secondary Outcomes (10)

• 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)

Study Arms (2)

10 mmHg Pneumoperitoneum

ACTIVE COMPARATOR

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

Diagnostic Test: 10 mmHg Pneumoperitoneum

14 mmHg Pneumoperitoneum

ACTIVE COMPARATOR

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

Diagnostic Test: 14 mmHg Pneumoperitoneum

Interventions

10 mmHg Pneumoperitoneum 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.

10 mmHg Pneumoperitoneum

14 mmHg Pneumoperitoneum 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.

14 mmHg Pneumoperitoneum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Engin Çetin: lead

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37782166 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 15, 2025
• Study Start: June 18, 2025
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)