Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multi-centre, noninferiority, randomized controlled trial

Autor: Riva, T., Greif, R., Disma, N., Bonfiglio, R., Kämpfer, M., Fuchs, A.
Rok vydání: 2023
Předmět:
DOI: 10.48350/184237
Popis: Background and Goal of Study: Tracheal intubation in neonates and infants is a potentially life-saving procedure. Videolaryngoscopy (VL) has been found to improve first attempt tracheal intubation success and reduce complications compared to direct laryngoscopy (DL) in children less than 12 months. Supplemental, periprocedural, oxygen may increase the likelihood of successful first attempt intubation due to an increase in safe apnea time. This multicenter, prospective randomized controlled trial tested the hypothesis that direct laryngoscopy is not inferior to videolaryngoscopy when using standard blades and supplemental oxygen is provided. Materials and Methods: From 26.10.2020 to 11.3.2022, we randomly assigned 250 neonates and infants aged less than 52 weeks post-menstrual age scheduled for elective tracheal intubation to either DL or VL (1:1 ratio) at seven tertiary level pediatric hospitals in Australia, Canada, Italy, Switzerland and USA. All infants received supplemental oxygen (1 L/Kg/min) during laryngoscopy until the correct tracheal tube position was confirmed. The primary outcome was the proportion of first-attempt tracheal intubation success between the two groups. A 10% non-inferiority margin between DL or VL was applied. Results and Discussion: 244 patients were included in the final analysis. There is insufficient evidence that DL is non-inferior to videolaryngoscopy (p>0.99). First-attempt tracheal intubation success rate with no desaturation was higher with VL (89.3%; n=108/121) compared to DL (78.9%; n=97/123), with an adjusted absolute risk difference 9.5% [95%-CI: 0.8-18.1%]; p = 0.033). The incidence of oxygen desaturation between the two groups was comparable (-2.5% [95%-CI: -9.6% to 4.6%]; p = 0.490). This international trial confirmed that first-attempt success rate for tracheal intubation in anesthetized neonates and young infants is significantly higher with VL than with DL. The low incidence of complications in both groups, might be related to the use of continuous supplemental oxygen and the expertise of staff at the tertiary level pediatric hospitals involved. Conclusion(s): The combination of videolaryngoscopy and supplemental oxygen should be considered a standardized practice when neonates and infants are intubated for general anesthesia. The exact amount of oxygen to be delivered needs to be determined.
Databáze: OpenAIRE