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

NCT05737407 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

  • Oxygen Toxicity
  • Anesthesia; Adverse Effect

Interventions

OTHER

LUS-guided choice of Peep

Choice of Peep guided by lung ultrasound to avoid atelectasis

OTHER

Standard choice of Peep

Choice of Peep according to standard practice

Sponsors & Collaborators

  • Vittore Buzzi Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
33 Weeks
Max Age
50 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-06-30
Completion
2024-12-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05737407 on ClinicalTrials.gov