Lung Ultrasound, Cholecystectomy, Atelectasis

NCT ID: NCT06664658

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups:

* PEEP 5 cm H2O
* PEEP 10 cm H2O
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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PEEP 5

Patients are in the group undergoing PEEP 5 cm h2o during surgery

Group Type ACTIVE_COMPARATOR

peep 5

Intervention Type PROCEDURE

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

peep 10

Patients are in the group undergoing PEEP 10 cm h2o during surgery

Group Type ACTIVE_COMPARATOR

peep 10

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Ezgi POLAT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turkey Istanbul Medeniyet University Faculty of Medicine Department of Anesthesiology and Reanimation

Istanbul, Kadikoy, Turkey (Türkiye)

Site Status

Istanbul Medeniyet Universty

Istanbul, kadıköy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Yu X, Zhai Z, Zhao Y, Zhu Z, Tong J, Yan J, Ouyang W. Performance of Lung Ultrasound in Detecting Peri-Operative Atelectasis after General Anesthesia. Ultrasound Med Biol. 2016 Dec;42(12):2775-2784. doi: 10.1016/j.ultrasmedbio.2016.06.010. Epub 2016 Sep 14.

Reference Type BACKGROUND
PMID: 27639431 (View on PubMed)

Other Identifiers

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IRB: Approval No. 2022/0257

Identifier Type: -

Identifier Source: org_study_id

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