Evaluation of Perioperative Lung Ultrasound Scores in Laparoscopic Pediatric Surgeries

NCT ID: NCT06072885

Last Updated: 2024-06-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Laparoscopic surgeries require carbon-dioxide into the abdomen which may occasionally lead to atelectasis. The extent of this atelectasis is not well documented in peri-operative period although it has been extensively researched in critical care set up. In this study, it is aimed to observe the ultrasonographic condition of lungs in laparoscopic pediatric surgeries. The hypothesis was the Lung Ultrasound Scores would worsen in those surgeries by the end of the operation. Aged between 1-18 years pediatric patients who are scheduled for laparoscopic surgeries will be included in the study to observe the changes in the lung visuals throughout the operation. For that, after safe endotracheal intubation first ultrasonography will be performed for the first (T1) time, and the second ultrasonography will be performed once the surgery is finished and before extubation (T2). Lastly, the third evaluation will be performed after 30 minutes in post anesthesia care unit (T3). Lung Ultrasound Score (LUS) is calculated as follows: Both hemi-thoraxes are divided into 6 different zones, and depending on the number of B-lines, which happens due to aeration loss in lung tissue, every zone is scored. If there is no B-line, it is zero points. If the B-lines in the visual lower than 4, the area is scored as 1 point. The areas with B-lines more than 3 is scored as 2 points. Furthermore, if there is any disruption on the pleural face, then the area is scored as 3 points. Accordingly, the worst case scenario refers 36 points, meaning the less the points the better the lung aeration.

Primary outcome is defined as T2 LUS which will show the actual condition of at the end of the surgery. For that, T1 scores and T2 scores will be compared. The secondary outcomes include T3 LUS, (T3-T1)LUS, intraoperative hemodynamics, length of stay in Post Anesthesia Care Unite, postoperative aldrete scores for discharging to ward, and intraoperative ventilation variables.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pulmonary Atelectasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic pediatric surgery

Pediatric patients who are scheduled for laparoscopic surgeries in supine position (e.g. laparoscopic appendectomy, laparoscopic cholecystectomy, laparoscopic nissen fundoplication)

Lung Ultrasound Scoring

Intervention Type OTHER

Pediatric Laparoscopic Surgery patients will be undergone Lung Ultrasound Scoring (LUS) at multiple times perioperatively. LUS is a pragmatic calculation reflecting lung aeration. Thorax is divided into 12 areas, and in every one of them LUS is applied to observe the lung condition. For that, if there are B-lines less than 4 in one area, it is scored as 1 point. For the areas containing more than 3 B-lines, it is scored as 2 points, and if there is any distortion on the pleural line, it is scored as 3 points. The areas with no B-lines is scored as 0 points. Considering these details, lungs with best conditions will reflect 0 points whereas the worst condition lungs will reflect 36 points. LUS will be performed after intubation, before extubation, and after 30th minute in the post anesthesia care unit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lung Ultrasound Scoring

Pediatric Laparoscopic Surgery patients will be undergone Lung Ultrasound Scoring (LUS) at multiple times perioperatively. LUS is a pragmatic calculation reflecting lung aeration. Thorax is divided into 12 areas, and in every one of them LUS is applied to observe the lung condition. For that, if there are B-lines less than 4 in one area, it is scored as 1 point. For the areas containing more than 3 B-lines, it is scored as 2 points, and if there is any distortion on the pleural line, it is scored as 3 points. The areas with no B-lines is scored as 0 points. Considering these details, lungs with best conditions will reflect 0 points whereas the worst condition lungs will reflect 36 points. LUS will be performed after intubation, before extubation, and after 30th minute in the post anesthesia care unit

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Laparoscopic pediatric surgeries
* Aged between 1-18 years

Exclusion Criteria

* Patients with Constitutional lung diseases
* Patients with Heart failure
* Patients with pulmonary hypertension
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Meltem Savran Karadeniz

MD, Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/796

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.