Using lung ultrasound to choose the best breathing support for newborns during anesthesia
Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia: a Randomized, Controlled Trial
This study is testing if using lung ultrasound can help doctors choose the best breathing support for newborns during surgery to see if it improves their breathing and reduces oxygen needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 33 Weeks to 50 Weeks |
| Sex | All |
| Sponsor | Vittore Buzzi Children's Hospital Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05737407 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using lung ultrasound (LUS) to guide the selection of positive end-expiratory pressure (PEEP) in newborns undergoing anesthesia. The study will compare LUS-guided PEEP with standard PEEP choices to determine if it can improve gas exchange and reduce the amount of oxygen needed during ventilation. Conducted at Vittore Buzzi Children's Hospital, the trial will involve infants under two months scheduled for surgery, with experienced anesthesiologists performing the procedures. The outcomes will include postoperative pulmonary complications, respiratory compliance, and hemodynamic parameters.
Who should consider this trial
Good fit: Ideal candidates are infants born after 33 weeks of gestation and up to 50 weeks post-conceptional age requiring general anesthesia for elective or urgent surgery.
Not a fit: Patients born before 33 weeks of gestation or those with cardiac or lung abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory outcomes and reduced oxygen toxicity in newborns undergoing anesthesia.
How similar studies have performed: While the use of lung ultrasound in anesthesia is gaining interest, this specific approach to guiding PEEP selection in neonates is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 intubation Exclusion Criteria: * 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
Where this trial is running
Milan
- Vittore Buzzi Cildren's Hospital — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Anna Camporesi, MD
- Email: anna.camporesi@asst-fbf-sacco.it
- Phone: +393355793744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.