RecruitingNot ApplicableNCT05737407

Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia

Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia: a Randomized, Controlled Trial


Sponsor

Vittore Buzzi Children's Hospital

Enrollment

280 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this RCT is to demonstrate that, in neonatal anesthesia, the use of Lung Ultrasound (LUS) to guide choice of best Positive End-Expiratory Pressure (Peep) - the one that efficiently avoids lung atelectasis - leads to better gas exchange in the lung thus can lead to reduction of FiO2 applied to ventilatory setting in order to achieve same peripheral saturations of oxygen (SpO2). Specific aims of the study are: 1. to determine if LUS-guided PEEP choice in neonatal anesthesia, compared to standard PEEP choice, can lead to reduction of FiO2 applied to the ventilatory setting in order to maintain same SpO2s. 2. to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours. 3. to compare static respiratory system compliance between groups. 4. to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups.


Eligibility

Min Age: 33 WeeksMax Age: 50 Weeks

Plain Language Summary

Simplified for easier understanding

This study investigates whether lung ultrasound — a bedside, radiation-free imaging tool — can guide the optimal setting of ventilator pressure (PEEP, or Positive End-Expiratory Pressure) during general anaesthesia for newborns and very young infants. Babies' lungs are particularly sensitive to collapse and over-inflation during surgery, and finding the right pressure balance is critical for preventing lung injury. Lung ultrasound can detect areas of collapsed or over-expanded lung in real time, potentially allowing more personalised and safer ventilation. Infants born after 33 weeks of pregnancy and up to 50 weeks of post-conceptional age who require elective or urgent surgery under general anaesthesia with a breathing tube are eligible. Babies born before 33 weeks, those with known heart or lung abnormalities, immune or metabolic diseases, or whose parents have not consented are excluded. During the procedure, lung ultrasound is performed alongside standard ventilator monitoring to guide PEEP adjustments. The study observes outcomes without introducing any extra invasive steps. This research is important because newborns are a uniquely vulnerable population during anaesthesia, and even small improvements in ventilation management can reduce the risk of post-operative lung complications and intensive care admissions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLUS-guided choice of Peep

Choice of Peep guided by lung ultrasound to avoid atelectasis

OTHERStandard choice of Peep

Choice of Peep according to standard practice


Locations(1)

Vittore Buzzi Cildren's Hospital

Milan, Italy

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NCT05737407


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