A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates☆, ☆☆

Barbosa, Rosilu F.; Simões e Silva, Ana C.; Silva, Yerkes P.

doi:10.1016/j.jped.2016.08.007

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Original articles • J. Pediatr. (Rio J.) 93 (4) • Jul-Aug 2017 • https://doi.org/10.1016/j.jped.2016.08.007 copy

A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates^☆ ☆ Please cite this article as: Barbosa RF, Simões e Silva AC, Silva YP. A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates. J Pediatr (Rio J). 2017;93:343-50. , ^☆☆ ☆☆ Study conducted at Universidade Federal de Minas Gerais (UFMG), Faculdade de Medicina, Belo Horizonte, MG, Brazil.

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objective:

To compare the short-term efficacy of surfactant administration by laryngeal mask airway versus endotracheal tube.

Methods:

Preterm infants (28-35 weeks of gestational age), weighing 1 kg or more, with respiratory distress syndrome, requiring nasal continuous positive airway pressure, with increased respiratory effort and/or fraction of inspired oxygen (FiO₂) ≥ 0.40 to maintain oxygen saturation 91-95%, were randomized to receive surfactant by LMA following nCPAP or by ETT following mechanical ventilation (MV). The primary outcome was a clinical response defined as FiO₂ ≤ 0.30 three hours after surfactant. Secondary outcomes for LMA group were: need of surfactant retreatment during the first 24 h, MV requirement, and presence of surfactant in gastric content.

Results:

Forty-eight patients were randomized; 26 in the LMA group and 22 in the ETT group. Six of 26 patients (23%) in the LMA group and five of 22 patients (22.7%) in the ETT group did not meet the primary outcome (p = 0.977). Fourteen (53.8%) of the LMA patients were not intubated nor ventilated; 12 (46.1%) were ventilated: for surfactant failure (23%), for nCPAP failure (11.5%), and for late complications (11.5%). Groups were similar regarding prenatal status, birth conditions, and adverse events. No significant gastric content was found in 61.5% of the LMA patients. Oxygen and second dose surfactant requirements, arterial/alveolar ratio, and morbidities were similar among groups.

Conclusions:

Surfactant administration by LMA showed short-term efficacy, with similar supplementary oxygen need compared to surfactant by ETT, and lower MV requirement. Further studies with larger sample size are necessary to confirm these results.

KEYWORDS
Laryngeal mask airway; Preterm infant; Pulmonary surfactant

	LMA group (n = 26)	ETT group (n = 22)	p-value
Median birth weight (g)	1515 (1025-2295)	1495 (1005-2515)	0.795^a a Mann-Whitney test.
Mean gestational age at birth (weeks)	31 1/7 (28-34)	31 4/7 (28-35)	0.539^b b t-Test.
Male gender (n)	18 (69.2%)	9 (40.9%)	0.049^d d X2 test.
Multiple gestation (n)	4 (15.3%)	5 (22.7%)	0.713^c c Fisher's exact test.
Median Apgar score at 5 min	9 (7-10)	9 (8-10)	0.927^a a Mann-Whitney test.
Vaginal delivery/cesarean section (n)	8/18 (69.2%)	5/17 (77.2%)	0.532^d d X2 test.
Antenatal steroids (n)	14 (53.8%)	17 (77.2%)	0.091^d d X2 test.
Self-inflated facemask-bag positive pressure ventilation at delivery room (n)	9 (34.6%)	6 (27.2%)	0.584^d d X2 test.
CPAP at delivery room (n)	14 (53.8%)	12 (54.5%)	0.961^d d X2 test.
Axillar temperature at NICU admission <36.5 °C (n)	17 (65.3%)	11 (50%)	0.366^d d X2 test.
Normal capillary perfusion ≥ 3+ (+ to 4+) (n)	26 (100%)	20 (90.9%)	0.205^c c Fisher's exact test.
Heart rate > 100 bpm (n)	26 (100%)	21 (95.4%)	0.458^c c Fisher's exact test.
Median mean blood pressure (mmHg)	38 (33-71)	40 (32-58)	0.855^a a Mann-Whitney test.
Median Silverman-Anderson score (0-10)	4 (0-7)	4 (2-6)	0.909^a a Mann-Whitney test.
Median FiO₂ on CPAP (0.30-1.0)	0.50	0.50	0.507^a a Mann-Whitney test.
Mean arterial blood gas SpO₂ (%)	89.5 (63-99)	92.8 (77-100)	0.286^b b t-Test.
Mean arterial blood gas pH	7.2 (7.0-7.4)	7.2 (7.1-7.3)	0.530^b b t-Test.
Median arterial blood gas PaO₂ (mmHg)	78.5 (39.0-167.0)	85.5 (52.7-195.0)	0.373^a a Mann-Whitney test.
Mean arterial blood gas PaCO₂ (mmHg)	52.9 (34.0-76.0)	50.9 (31.0-67.0)	0.499^b b t-Test.
Median arterial blood gas HCO₃ (mEq/L)	23.1 (14.8-26.1)	22.7 (15.7-26.0)	0.716^a a Mann-Whitney test.
Median a/A ratio	0.2 (0.1-0.9)	0.3 (0.1-1.0)	0.514^a a Mann-Whitney test.
Median NIPS (0-4)	2	2.5	0.102^a a Mann-Whitney test.

SA score and FiO₂ - 3 and 6 h after surfactant. a/A ratio and PaCO₂ - 3 h after surfactant. NIPS - after LMA or ETT	Procedure		p-value
	LMA (n = 26)	ETT (n = 22)
SA score 3 h Median	2.0	0.0	0.0001^a a Mann-Whitney test.
SA score 6 h Median	0.5	0.0	0.017^a a Mann-Whitney test.
FiO₂ 3 h Median	0.30	0.25	0.111^a a Mann-Whitney test.
FiO₂ 6 h Median	0.30	0.25	0.468^a a Mann-Whitney test.
a/A ratio 3 h Mean	0.4	0.4	0.950^b b t-Test.
PaCO₂ 3 h Median	44.5	41.0	0.425^a a Mann-Whitney test.
NIPS after Median	2.0	0.0	0.0000^a a Mann-Whitney test.

Variable	Procedure		p-value
	LMA (n = 26)	ETT (n = 22)
FiO₂ ≤ 0.30 (yes/no)	20/6 (CI 0.11-0.42)	17/5 (CI 0.10-0.43)	0.977^a a χ2 test.
Number surfactant treatment (one/two)	20/6	18/4	0.735^b b Fisher's exact test.

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[1] * Corresponding author. E-mail:rosilu@gmail.com (R.F. Barbosa).