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NCT05737407
Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia
Conditions: Oxygen Toxicity, Anesthesia; Adverse Effect
Sex: All
Ages: 33 Weeks – 50 Weeks
Phase: NA
Enrollment: 280
Sponsor: Vittore Buzzi Children's Hospital
Location: Italy
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: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.to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours.to compare static respiratory system compliance between groups.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 Criteria
Inclusion Criteria:patients born after 33 weeks of gestationand up to the age of 50 post-conceptional weeks undergoing elective or urgent surgery requiring general anesthesia with endotracheal intubationExclusion Criteria:born at less than 33 weeks of gestationpatients with signs or symptoms of cardiac or lung abnormalities or diseasespatients with suspected/confirmed immune diseases, known or suspected metabolic or genetic conditionsno parental consent is obtained
Source: ClinicalTrials.gov (NCT05737407). StuddyBuddy aggregates publicly available trial information.