Clinical trial NCT06072885: Evaluation of Perioperative Lung Ultrasound Scores in Laparoscopic Pediatric Surgeries
Official title: Prospective Observational Evaluation of Perioperative Lung Ultrasound Scores in Laparoscopic Pediatric Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pulmonary Atelectasis
Keywords: pediatric anesthesia
Atelectasis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who are scheduled for laparoscopic abdomen surgeries that will be performed in supine position

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Lung Ultrasound Score in T2 time point (After surgery finish, before extubation)
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Lung Ultrasound Score in T3 time point (30 minutes after admission to post anesthesia care unit
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
Study officials:
References: