Comparison of two intubation procedure in neonates: residents assisted by video-laryngoscopy versus neonatologist using direct laryngoscopy: a non-inferiority, multicenter, open-labelled clinical trial

Abstract

Background: Neonatal intubation is an important procedure that neonatologist do in NICU and is fundamental that everyone knows how to perform it. However, this procedure has difficulties and risks. Neonates (NN) is very vulnerable group of patients in a hospital and often they have many complications during endotracheal intubation (EI). Throughout the years, technology has developed to improve the techniques used during clinical practice, but EI is a skill that has been used less and less. A recent review shows that if there is a previous EI training we can improve the intubation skill in less experienced professionals. Objective: To analyze the complication rate using VL by a resident versus direct laryngoscopy (DL) by a neonatologist in a NN intubation. Methods: the design is a non-inferiority, prospective, multicenter, randomized, open-labelled, parallel-group trial. We will enroll 1462 patients during 1 year from 13 Spanish hospitals. These patients will be randomized into two group, 731 EI will be done by a neonatologist with direct laryngoscopy (DL) and the other 731 will be done by a resident with video-laryngoscopy (VL). Main outcomes complication rate during the intervention. The analysis of response to treatment for endpoint variable (complication rate) between independent treatment and control groups (main objective of the proposal) will be performed by a lineal regression analysis