Daniele Trevisanuto1, Francesco Cavallin2, Loi Ngoc Nguyen3, Tien Viet Nguyen3, Linh Dieu Tran3, Chien Dinh Tran4, Nicoletta Doglioni5, Massimo Micaglio6, Luciano Moccia7. 1. Department of Women and Children Health, University of Padua, Azienda Ospedaliera di Padova, Padova, Italy; Amici della Neonatologia Trentina, Trento, Italy. Electronic address: trevo@pediatria.unipd.it. 2. Independent Statistician, Padova, Italy. 3. Department of Neonatal Intensive Care, National Hospital of Obstetrics and Gynecology, Ha Noi, Viet Nam. 4. Breath of Life Program - East Meets West Foundation, Oakland, CA. 5. Department of Women and Children Health, University of Padua, Azienda Ospedaliera di Padova, Padova, Italy. 6. Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. 7. Amici della Neonatologia Trentina, Trento, Italy; Breath of Life Program - East Meets West Foundation, Oakland, CA.
Abstract
OBJECTIVE: To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. STUDY DESIGN: We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. RESULTS:We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. CONCLUSIONS: In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT01963936.
RCT Entities:
OBJECTIVE: To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. STUDY DESIGN: We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. RESULTS: We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. CONCLUSIONS: In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT01963936.