Laryngoscopy for Neonatal and Infant Airway Management with Supplemental Oxygen At Different Flow Rates (OPTIMISE-2)

Launched by THOMAS RIVA · Jul 27, 2023

Keywords

ClinConnect Summary

The OPTIMISE-2 clinical trial is studying the best way to provide extra oxygen to young children, especially newborns and infants, during a procedure called tracheal intubation. This procedure is often necessary for patients who need help with their breathing, whether for surgery or other medical reasons. The researchers want to find out if using low or high levels of oxygen during this process makes a difference in how well the intubation goes.

To participate in this study, children up to 52 weeks old who need help with breathing can be included, as long as their legal guardians give written consent. However, some children may not be eligible, such as those with certain heart conditions or previous difficulties with intubation. If a child joins the study, they will receive care in either an operating room or an intensive care unit, and the team will closely monitor their oxygen levels and overall health during the procedure. This research aims to improve safety and effectiveness for young patients undergoing airway management.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical indications.
• • Neonates and infants up to 52 weeks postconceptual age, with legal guardians providing written informed consent before the intervention
• Exclusion Criteria:
• • Prediction of difficult intubation upon physical examination or previous history of difficult intubation, mandating a technique different than direct laryngoscopy to secure the airway;
• • Congenital heart disease demanding FiO2 \< 1.0
• • Cardiopulmonary collapse requiring advanced life support
• • Intubation for emergency surgical and non-surgical indications.