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

Inclusion Criteria1

  • 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 intubation

Exclusion Criteria4

  • born at less than 33 weeks of gestation
  • patients with signs or symptoms of cardiac or lung abnormalities or diseases
  • patients with suspected/confirmed immune diseases, known or suspected metabolic or genetic conditions
  • no parental consent is obtained

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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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