LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

Abstract

BackgroundThe most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists.Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation.Methods/designThis will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life.Trial registrationClinicalTrials.gov identifier: NCT01963936 (October 11, 2013).

Comparative Study of laryngeal mask airway Supreme and laryngeal mask airway Classic in paralyzed patients

“…Second attempt insertion rate for LMA Classic was 13.9% and 1.5% in LMA Supreme group. Results of our study were correlated with different studies [10][11][12][13][14]. In current study all three overall failed insertion and six of the nine failed first attempt insertion occurred during the insertion of Supreme LMA, suggested that the order of insertion and inadequate depth of anaesthesia may have contributed to likelihood of failure however there was no physiological response to insertion during any of the failed attempts.…”

Interdisziplinär konsentierte Stellungnahme zum Atemwegsmanagement mit supraglottischen Atemwegshilfen in der Kindernotfallmedizin

“…In retrospektiven Anwendungsbeobachtungen konnte die LM sogar bei Neugeborenen ab 1 kgKG erfolgreich eingesetzt werden [12,35,40].…”