- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824506
Ultrasound for Postop Lung Issues in Low-Flow Anesthesia
Evaluation of Early Postoperative Pulmonary Complications That Can be Detected by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy With Low-flow Anesthesia
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative atelectasis is a common complication that can develop in all patients receiving general anesthesia. The frequency of atelectasis increases due to increased intraabdominal pressure, especially in laparoscopic surgeries performed with pneumoperitoneum. For this reason, in order to prevent postoperative complications related to the lungs, it is extremely important to recognize atelectasis at an early stage, as well as to recognize the mechanisms that will cause atelectasis and avoid them.
Lung ultrasonography (Lung USG) draws attention for the rapid, cheap, safe and reliable detection of postoperative atelectasis. The fact that it can be applied at the bedside and can be easily repeated makes this method valuable. In the literature and in daily practice, it is seen that anesthesiologists commonly apply inhalation anesthesia with different fresh gas flow (FGF) rates during general anesthesia.
As defined by Baker and Simionescu, in low-flow anesthesia, FGF varies between 0.5 and 1 liter per minute. It has been shown that all types of flow are safe with modern anesthesia machines.
This study aims to demonstrate the effect of low-flow anesthesia (LFA) on pulmonary complications and, in particular, atelectasis that may develop after laparoscopic cholecystectomy operations, using a non-invasive, rapidly applicable, and proven method such as Lung USG.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hilal SAZAK, MD
- Phone Number: +90 312 356 90 00
- Email: hilalgun@yahoo.com
Study Contact Backup
- Name: Necla DERELI, MD
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Ataturk Sanatorium Research and Training Hospital
-
Contact:
- Mustafa Ozgur CIRIK, Assoc. Prof.
- Phone Number: 2031 90 312 567 70 00
- Email: dr.ozgurr@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with informed consent
- Patients scheduled for laparoscopic cholecystectomy
- Patients with a Body Mass Index between 18-35 kg/m²
- Patients in the American Society of Anesthesiologist (ASA) 1-2-3 category
Exclusion Criteria:
- Patients with emergency surgery planned
- Patients with ASA 4 and above
- Patients with lung disease
- Patients who have undergone thoracic surgery
- Pregnancy
- Patients with a preoperative Lung Ultrasound Score of 2 or 3 in any lung region
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Low-Flow Anesthesia Group
As this study is observational in nature, no interventions will be performed by the research team.
The study will involve a single group, within which the incidence and prevalence of the outcomes will be assessed.
|
No interventions will be performed by the research team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of postoperative atelectasis
Time Frame: 1 hour peroperatively
|
Incidence of postoperative atelectasis determined by lung ultrasonography in patients undergoing laparoscopic cholecystectomy with low-flow anesthesia
|
1 hour peroperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of other postoperative pulmonary complications
Time Frame: 1 hour peroperatively
|
Other postoperative pulmonary complications that may develop and be detected by ultrasonography such as pneumothorax, pleural effusion, pulmonary edema
|
1 hour peroperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mustafa Özgür CIRIK, MD, Ankara Ataturk Sanatorium Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SanatoryumEAH-AK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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