Perioperative Diaphragmatic ExcursionNCT07332728
Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy
An observational study of Perioperative Diaphragmatic Excursion, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy and the associated pneumoperitoneum can impair diaphragmatic mechanics and reduce postoperative oxygenation. This prospective observational study aims to evaluate perioperative changes in diaphragmatic excursion measured by ultrasonography and to investigate their association with early… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perioperative Diaphragmatic Excursion
- What is being tested?
- Standard perioperative care with observational diaphragm ultrasonography
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18-75 years undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care center. Eligible participants are patients without known diaphragmatic dysfunction or severe underlying pulmonary disease, in whom perioperative diaphragm ultrasonography and postoperative oxygenation measurements can be reliably performed. All participants provide written informed consent and receive standard perioperative care without any study-related intervention.
Who may be able to join
- Adults aged 18-75 years
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Able to undergo diaphragm ultrasonography (no preoperative barrier to assessment)
- Able to cooperate with preoperative and early postoperative diaphragm measurements
- Postoperative oxygenation data available (SpO₂, FiO₂, and SpO₂/FiO₂ can be recorded)
- Provided written informed consent
Who cannot join
- Morbid obesity (BMI ≥ 40 kg/m²)
- Known diaphragmatic paralysis, phrenic nerve injury, or hemidiaphragm dysfunction
- Severe COPD, restrictive lung disease, or advanced parenchymal lung disease
- Preoperative home oxygen therapy or CPAP/BiPAP/home mechanical ventilation
- Conversion to open surgery (laparoscopic → open)
- Hemodynamic instability preoperatively or intraoperatively; emergency/complicated surgery
Show all 10Show fewer
- Factors preventing ultrasound assessment (e.g., marked upper abdominal gas, large scar/wound, severe subcutaneous edema)
- Same-day discharge cases with <24-hour observation
- Inability to complete measurements (e.g., severe cognitive impairment, poor cooperation, severe pain preventing measurement)
- Incomplete data not compatible with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Prospective Observational Evaluation of the Association Between Perioperative Changes in Diaphragmatic Excursion and Postoperative Oxygenation and Hypoxemia in Patients Undergoing Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy and the associated pneumoperitoneum can impair diaphragmatic mechanics and reduce postoperative oxygenation. This prospective observational study aims to evaluate perioperative changes in diaphragmatic excursion measured by ultrasonography and to investigate their association with early postoperative oxygenation parameters and hypoxemia. By correlating diaphragmatic excursion changes with SpO₂/FiO₂ and the ROX index, the study seeks to clarify the physiological contribution of diaphragmatic dysfunction to postoperative hypoxemia in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Perioperative Diaphragmatic Excursion
- Being tested
- Standard perioperative care with observational diaphragm ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard perioperative care with observational diaphragm ultrasonographyOther
No therapeutic intervention is applied in this study. All patients receive standard perioperative anesthesia and surgical care according to institutional routine. Diaphragmatic excursion is assessed non-invasively using ultrasonography in the preoperative period and at 15 minutes postoperatively in the post-anesthesia care unit. Oxygenation parameters and respiratory variables are recorded for observational analysis only.
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragmatic excursion (ΔDE) and postoperative hypoxemia
Association between perioperative change in diaphragmatic excursion (ΔDE) and postoperative hypoxemia, defined as SpO₂ < 92% and/or a clinically significant decrease in the SpO₂/FiO₂ ratio.
Measured: Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perioperative Diaphragmatic ExcursionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332728
- Sponsor's protocol ID
- serpil Diaphragm US
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rustagi PS, Yadav A, Nellore SS. Ultrasonographic evaluation of diaphragmatic excursion changes after major laparoscopic surgeries in the Trendelenburg position under general anaesthesia: A prospective observational study. Indian J Anaesth. 2023 Nov;67(Suppl 4):S274-S280. doi: 10.4103/ija.ija_643_23. Epub 2023 Nov 21.
PubMed 38187984Yao XY, Li HM, Sun BW, Zhang YY, Feng JG, Jia J, Liu L. Ultrasound assessment of diaphragmatic dysfunction in non-critically ill patients: relevant indicators and update. Front Med (Lausanne). 2024 Jun 18;11:1389040. doi: 10.3389/fmed.2024.1389040. eCollection 2024.
PubMed 38957305Yan T, Yu Q, Li CQ, Xu ZZ, Ma JH, Xie M, Zhu SN, Wang DX, Li SL. Maximal inspiratory diaphragmatic ultrasound predicts postoperative pulmonary complications after upper abdominal surgery. Ann Intensive Care. 2025 Aug 18;15(1):121. doi: 10.1186/s13613-025-01531-2.
PubMed 40824343
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Evaluation of the Association Between Perioperative Changes in Diaphragmatic Excursion and Postoperative Oxygenation and Hypoxemia in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07332728
- Acronym / sponsor ID
- serpil Diaphragm US
- Conditions
- Perioperative Diaphragmatic Excursion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 Jan 2026 (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.
Laparoscopic cholecystectomy and the associated pneumoperitoneum can impair diaphragmatic mechanics and reduce postoperative oxygenation. This prospective observational study aims to evaluate perioperative changes in diaphragmatic excursion measured by ultrasonography and to investigate their association with early postoperative oxygenation parameters and hypoxemia. By correlating diaphragmatic excursion changes with SpO₂/FiO₂ and the ROX index, the study seeks to clarify the physiological contribution of diaphragmatic dysfunction to postoperative hypoxemia in patients undergoing laparoscopic cholecystectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18-75 years undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care center. Eligible participants are patients without known diaphragmatic dysfunction or severe underlying pulmonary disease, in whom perioperative diaphragm ultrasonography and postoperative oxygenation measurements can be reliably performed. All participants provide written informed consent and receive standard perioperative care without any study-related intervention.
Key inclusion criteria (6 listed)
- Adults aged 18-75 years
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- Able to undergo diaphragm ultrasonography (no preoperative barrier to assessment)
- Able to cooperate with preoperative and early postoperative diaphragm measurements
- Postoperative oxygenation data available (SpO₂, FiO₂, and SpO₂/FiO₂ can be recorded)
Key exclusion criteria (10 listed)
- Morbid obesity (BMI ≥ 40 kg/m²)
- Known diaphragmatic paralysis, phrenic nerve injury, or hemidiaphragm dysfunction
- Severe COPD, restrictive lung disease, or advanced parenchymal lung disease
- Preoperative home oxygen therapy or CPAP/BiPAP/home mechanical ventilation
- Conversion to open surgery (laparoscopic → open)
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 |
|---|---|---|
| Standard perioperative care with observational diaphragm ultrasonographyNo therapeutic intervention is applied in this study. All patients receive standard perioperative anesthesia and surgical care according to institutional routine. Diaphragmatic excursion is assessed non-invasively using ultrasonography in the preoperative period and at 15 minutes postoperatively in the post-anesthesia care unit. Oxygenation parameters and respiratory variables are recorded for observational analysis only. | Other | – |
Primary outcome
diaphragmatic excursion (ΔDE) and postoperative hypoxemia
Time frame: Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).
Association between perioperative change in diaphragmatic excursion (ΔDE) and postoperative hypoxemia, defined as SpO₂ < 92% and/or a clinically significant decrease in the SpO₂/FiO₂ ratio.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Results publication: PubMed 38187984Rustagi PS, Yadav A, Nellore SS. Ultrasonographic evaluation of diaphragmatic excursion changes after major laparoscopic surgeries in the Trendelenburg position under general anaesthesia: A prospective observational study. Indian J Anaesth. 2023 Nov;67(Suppl 4):S274-S280. doi: 10.4103/ija.ija_643_23. Epub 2023 Nov 21.
- Results publication: PubMed 38957305Yao XY, Li HM, Sun BW, Zhang YY, Feng JG, Jia J, Liu L. Ultrasound assessment of diaphragmatic dysfunction in non-critically ill patients: relevant indicators and update. Front Med (Lausanne). 2024 Jun 18;11:1389040. doi: 10.3389/fmed.2024.1389040. eCollection 2024.
- Results publication: PubMed 40824343Yan T, Yu Q, Li CQ, Xu ZZ, Ma JH, Xie M, Zhu SN, Wang DX, Li SL. Maximal inspiratory diaphragmatic ultrasound predicts postoperative pulmonary complications after upper abdominal surgery. Ann Intensive Care. 2025 Aug 18;15(1):121. doi: 10.1186/s13613-025-01531-2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Diaphragmatic Excursion, run by Istinye University 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diaphragmatic excursion (ΔDE) and postoperative hypoxemia (time frame: Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).). 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 NCT07332728, which also lists 3 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 14 Jan 2026.