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).
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
- Conditions the study is for
- Airway Edema, Perioperative Complication, Pneumoperitoneum
- 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
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
- Conditions
- Airway Edema, Perioperative Complication, Pneumoperitoneum
- 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 group | Role | What they receive |
|---|---|---|
| 10 mmHg Pneumoperitoneum | Active comparator | Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg. Receives: Diagnostic Test: 10 mmHg Pneumoperitoneum |
| 14 mmHg Pneumoperitoneum | Active comparator | Patients 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.
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)
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
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
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
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
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)
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)
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)
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)
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)
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.
- First posted15 Jun 2025
- Study start18 Jun 2025
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Engin Çetin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Engin Çetin, Kocaeli City Hospital
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 37782166Cetin 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Airway Edema Induced by Intra-abdominal Pressure During Laparoscopic Cholecystectomy: A Prospective, Double-Blind, Randomized Study
- ClinicalTrials.gov ID
- NCT07021482
- Acronym / sponsor ID
- KSH-ANREA-EC-01
- Conditions
- Airway Edema, Perioperative Complication, Pneumoperitoneum
- Keywords
- Airway Ultrasound, Upper Airway Edema, Pneumoperitoneum, Intra-abdominal Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Engin ÇetinOther government
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| 10 mmHg Pneumoperitoneum | Active comparator | Diagnostic Test: 10 mmHg PneumoperitoneumPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 10 mmHg. |
| 14 mmHg Pneumoperitoneum | Active comparator | Diagnostic Test: 14 mmHg PneumoperitoneumPatients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- History of difficult intubation
- Upper respiratory tract infection
- Obstructive sleep apnea or STOP-Bang score ≥3
- Severe cardiopulmonary disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mmHg PneumoperitoneumLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 10 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. | Diagnostic test | 10 mmHg Pneumoperitoneum |
| 14 mmHg PneumoperitoneumLaparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed. | Diagnostic test | 14 mmHg Pneumoperitoneum |
Primary outcome
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
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.
10 secondary outcomes
ultrasonographic airway parameter -tongue width
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
ultrasonographic airway parameter -tongue volume
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
ultrasonographic airway parameter-pharyngeal thickness
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
ultrasonographic airway parameter- neck circumference
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
oxygen saturation changes
Time frame: Immediately after extubation and during early recovery (within the first 2 hours postoperative)
hoarseness
Time frame: Immediately after extubation and during early recovery (within the first 2 hours postoperative)
stridor
Time frame: Immediately after extubation and during early recovery (within the first 2 hours postoperative)
re-intubation
Time frame: Immediately after extubation and during early recovery (within the first 2 hours postoperative)
sore throat
Time frame: Immediately after extubation and during early recovery (within the first 2 hours postoperative)
Correlation Between Intravenous Fluid Volume and Airway Edema
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 37782166Aytac 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.
- Derived from this study: PubMed 41942843Cetin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.