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Airway EdemaNCT07021482

Ultrasound Assessment of Airway Edema During Laparoscopic Cholecystectomy

A study testing 10 mmHg Pneumoperitoneum and 14 mmHg Pneumoperitoneum in people with Airway Edema and Perioperative Complication, run by Engin Çetin at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, double-blind, randomized clinical trial aims to investigate the development of airway edema associated with intra-abdominal pressure during laparoscopic cholecystectomy. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
10 mmHg Pneumoperitoneum and 14 mmHg Pneumoperitoneum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2025to 17 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Sciences Kocaeli City Hospital

    Kocaeli, Izmit, 41100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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

Being tested
10 mmHg Pneumoperitoneum, 14 mmHg Pneumoperitoneum
Keywords
Airway Ultrasound, Upper Airway Edema, Pneumoperitoneum, Intra-abdominal Pressure
Medical subject headings
Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 mmHg PneumoperitoneumDiagnostic 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 PneumoperitoneumDiagnostic test

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

Study groups in NCT07021482
Study groupRoleWhat they receive
10 mmHg PneumoperitoneumActive comparatorPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg.
Receives: Diagnostic Test: 10 mmHg Pneumoperitoneum
14 mmHg PneumoperitoneumActive comparatorPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.
Receives: Diagnostic Test: 14 mmHg Pneumoperitoneum

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. ultrasonographic airway parameter -tongue width

    To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure.

    Measured: 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

  2. ultrasonographic airway parameter -tongue volume

    To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure.

    Measured: 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

  3. ultrasonographic airway parameter-pharyngeal thickness

    To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure.

    Measured: 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

  4. ultrasonographic airway parameter- neck circumference

    To compare the effect of two different pneumoperitoneum pressures (10 mmHg vs. 14 mmHg) on upper airway edema during laparoscopic cholecystectomy. The degree of edema will be evaluated by changes in ultrasonographic measurements of upper airway structures (e.g., tongue thickness, midsagittal cross-sectional area, pharyngeal wall thickness) before and after the procedure.

    Measured: 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

  5. oxygen saturation changes

    To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity.

    Measured: Immediately after extubation and during early recovery (within the first 2 hours postoperative)

  6. hoarseness

    To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity.

    Measured: Immediately after extubation and during early recovery (within the first 2 hours postoperative)

  7. stridor

    To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity.

    Measured: Immediately after extubation and during early recovery (within the first 2 hours postoperative)

  8. re-intubation

    To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity.

    Measured: Immediately after extubation and during early recovery (within the first 2 hours postoperative)

  9. sore throat

    To evaluate the clinical impact of pneumoperitoneum pressure (10 mmHg vs. 14 mmHg) on postoperative airway outcomes. Clinical indicators such as oxygen saturation changes, signs of airway obstruction, hoarseness, sore throat, hypoxia, stridor, and re-intubation will be recorded. The incidence of these complications will be compared between groups to assess whether higher pressure is associated with increased airway-related morbidity.

    Measured: Immediately after extubation and during early recovery (within the first 2 hours postoperative)

  10. Correlation Between Intravenous Fluid Volume and Airway Edema

    To evaluate the correlation between the total intravenous fluid volume administered intraoperatively and the degree of airway edema, as measured by changes in ultrasonographic airway parameters (e.g., tongue thickness, pharyngeal wall thickness) at defined time points.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start18 Jun 2025
  3. Primary completion17 Sep 2025
  4. Study completion17 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021482
Sponsor's protocol ID
KSH-ANREA-EC-01
Status last verified
Nov 2025
First submitted
5 Jun 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37782166
  • Cetin E, Gunel B, Yilmaz M, Civraz AZT, Hosgoz MT. Effects of different pneumoperitoneum pressures on the upper airway assessed by ultrasonography: a prospective, randomized, observer-blinded clinical study. BMC Anesthesiol. 2026 Apr 6;26(1):303. doi: 10.1186/s12871-026-03801-3.

    PubMed 41942843

Questions about this trial

What is this clinical trial studying?

A study testing 10 mmHg Pneumoperitoneum and 14 mmHg Pneumoperitoneum in people with Airway Edema and Perioperative Complication, run by Engin Çetin at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lateral Pharyngeal Wall Thickness Measured by Airway Ultrasound (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021482, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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