Lung Ultrasound, Cholecystectomy, Atelectasis

October 28, 2024 updated by: Ezgi POLAT, Istanbul Medeniyet University

Assessment of the Impact of Two Different PEEP Levels on Pulmonary Functions in Laparoscopic Cholecystectomy Using Ultrasound

Atelectasis is an important complication that can be seen during general anesthesia, especially in patients with lung problems and in patients having pneumoperitoneum. Application of PEEP during anesthesia may reduce the incidence of atelectasis.Lung ultrasonography is a tool that is easily accessible, can be applied at the bedside, is non-invasive, does not cause radiation exposure, and is increasingly used in daily practice in operating rooms. In this study, it was aimed to evaluate the occurrence of atelectasis by using lung ultrasound, and to investigate the effectiveness of ultrasound in determining the risk of developing atelectasis in patients ventilated with different PEEP values during general anesthesia. The study was conducted in 60 patients aged 18 and over, from ASA I-III groups, who were planned to undergo laparoscopic cholecystectomy surgery at the Istanbul Medeniyet University Göztepe Training and Research Hospital General Surgery Clinic, and their written and verbal informed consents were obtained. The patients included in the study were divided into 2 groups. Among the patients who were going to be operated, 5 PEEP were applied to Group I (n=30) cases, and 10 PEEP to Group II (n=30) cases during ventilation with anesthesia device. All patients were evaluated by transthoracic lung ultrasonography before anesthetic induction, after tracheal intubation, after pneumoperitoneum, and 15 minutes after recovery from anesthesia. According to the lung USG protocol, a total of 6 regions, including 2 quadrants of each hemi-thorax anterior wall, 2 right and left lateral walls, and 2 quadrants of the posterior wall, a total of 12 regions in each patient were scanned, and the images were evaluated. According to the modified lung USG scoring system, each region was scored between 0-3 consistent with the degree of atelectasis. The total score was calculated for each patient. Hemodynamic follow-up of the patients was performed. Anesthesia times, surgery times, and pneumoperitoneum times were recorded and compared.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kadikoy
      • Istanbul, Kadikoy, Turkey, 34720
        • Turkey Istanbul Medeniyet University Faculty of Medicine Department of Anesthesiology and Reanimation
    • Kadıköy
      • Istanbul, Kadıköy, Turkey
        • Istanbul Medeniyet Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients are aged 18 and over, from ASA I-III groups, who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria:

  • Patients who do not give consent
  • Patients who have previously undergone thoracic surgery
  • Patients with a body mass index > 40 kg/m²
  • Patients with severe COPD
  • Patients with serious pulmonary diseases
  • Patients diagnosed with obstructive sleep apnea syndrome
  • ASA IV patients
  • Patients with advanced cardiac and neurological diseases
  • Patients with mental retardation and limited cooperation
  • Patients who terminate their participation in the study for any reason during the trial
  • Pediatric age group Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PEEP 5
Patients are in the group undergoing PEEP 5 cm h2o during surgery
Procedure: peep 5
he patients included in the study were divided into 2 groups. Among the patients who were going to be operated, 5 PEEP were applied to Group I (n=30) cases, and 10 PEEP to Group II (n=30) cases during ventilation with anesthesia device. All patients were evaluated by transthoracic lung ultrasonography before anesthetic induction, after tracheal intubation, after pneumoperitoneum, and 15 minutes after recovery from anesthesia. According to the lung USG protocol, a total of 6 regions, including 2 quadrants of each hemi-thorax anterior wall, 2 right and left lateral walls, and 2 quadrants of the posterior wall, a total of 12 regions in each patient were scanned, and the images were evaluated. According to the modified lung USG scoring system, each region was scored between 0-3 consistent with the degree of atelectasis
Active Comparator: peep 10
Patients are in the group undergoing PEEP 10 cm h2o during surgery
Procedure: peep 10
he patients included in the study were divided into 2 groups. Among the patients who were going to be operated, 5 PEEP were applied to Group I (n=30) cases, and 10 PEEP to Group II (n=30) cases during ventilation with anesthesia device. All patients were evaluated by transthoracic lung ultrasonography before anesthetic induction, after tracheal intubation, after pneumoperitoneum, and 15 minutes after recovery from anesthesia. According to the lung USG protocol, a total of 6 regions, including 2 quadrants of each hemi-thorax anterior wall, 2 right and left lateral walls, and 2 quadrants of the posterior wall, a total of 12 regions in each patient were scanned, and the images were evaluated. According to the modified lung USG scoring system, each region was scored between 0-3 consistent with the degree of atelectasis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The study will terminate once a population of 60 patients is reached.
Time Frame: Postoperative 24 hours
All patients were evaluated by transthoracic lung ultrasonography before anesthetic induction, after tracheal intubation, after pneumoperitoneum, and 15 minutes after recovery from anesthesia. According to the lung USG protocol, a total of 6 regions, including 2 quadrants of each hemi-thorax anterior wall, 2 right and left lateral walls, and 2 quadrants of the posterior wall, a total of 12 regions in each patient were scanned, and the images were evaluated. According to the modified lung USG scoring system, each region was scored between 0-3 consistent with the degree of atelectasis
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB: Approval No. 2022/0257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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