Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial

doi:10.1016/j.jpeds.2015.04.051

The Journal of Pediatrics

Volume 167, Issue 2, August 2015, Pages 286-291.e1

https://doi.org/10.1016/j.jpeds.2015.04.051 Get rights and content

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.

Section snippets

Methods

This was a single center, prospective, unblinded, randomized, controlled trial conducted at the National Hospital of Obstetrics and Gynecology, Ha Noi, Vietnam. This center, where about 21 000 deliveries occur every year, is a level III hospital with large referral services for maternal and neonatal care. In the Neonatal Department, there are 60 and 90 intensive care and postintensive care cots, respectively. Six mechanical ventilators and 30 continuous positive airway pressure machines are

Results

Patients were enrolled from November 3, 2012, to December 21, 2013 (trial was registered on October 11, 2013). During the study period, 756 of 25.211 infants ≥34-week gestation and/or birth weight >1500 g born at the National Hospital of Obstetrics and Gynecology needed PPV in delivery room. Of the 599 who were assessed for eligibility, 142 were randomized, 71 were assigned to SLMA group, and 71 to face mask group. No dropouts occurred (Figure; available at www.jpeds.com).

The 2 groups were

Discussion

We found that SLMA was more effective than face mask in preventing endotracheal intubation in neonates needing resuscitation at birth. In 2013, a systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of 4 RCTs stating that fewer infants in the LMA group required endotracheal intubation (1.5%) compared with the face mask group (12.0%).¹⁴ Our results confirm that effective PPV can be more frequently achieved with a supraglottic device than with

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Cited by (57)

Airway management in neonates and infants: European Society of Anaesthesiology and Intensive Care and British Journal of Anaesthesia joint guidelines
2024, British Journal of Anaesthesia
Airway management is required during general anaesthesia and is essential for life-threatening conditions such as cardiopulmonary resuscitation. Evidence from recent trials indicates a high incidence of critical events during airway management, especially in neonates or infants. It is important to define the optimal techniques and strategies for airway management in these groups. In this joint European Society of Anaesthesiology and Intensive Care (ESAIC) and British Journal of Anaesthesia (BJA) guideline on airway management in neonates and infants, we present aggregated and evidence-based recommendations to assist clinicians in providing safe and effective medical care. We identified seven main areas of interest for airway management: i) preoperative assessment and preparation; ii) medications; iii) techniques and algorithms; iv) identification and treatment of difficult airways; v) confirmation of tracheal intubation; vi) tracheal extubation, and vii) human factors. Based on these areas, Population, Intervention, Comparison, Outcomes (PICO) questions were derived that guided a structured literature search. GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to formulate the recommendations based on those studies included with consideration of their methodological quality (strong ‘1’ or weak ‘2’ recommendation with high ‘A’, medium ‘B’ or low ‘C’ quality of evidence). In summary, we recommend: 1. Use medical history and physical examination to predict difficult airway management (1C). 2. Ensure adequate level of sedation or general anaesthesia during airway management (1B). 3. Administer neuromuscular blocker before tracheal intubation when spontaneous breathing is not necessary (1C). 4. Use a videolaryngoscope with an age-adapted standard blade as first choice for tracheal intubation (1B). 5. Apply apnoeic oxygenation during tracheal intubation in neonates (1B). 6. Consider a supraglottic airway for rescue oxygenation and ventilation when tracheal intubation fails (1B). 7. Limit the number of tracheal intubation attempts (1C). 8. Use a stylet to reinforce and preshape tracheal tubes when hyperangulated videolaryngoscope blades are used and when the larynx is anatomically anterior (1C). 9. Verify intubation is successful with clinical assessment and end-tidal CO₂ waveform (1C). 10. Apply high-flow nasal oxygenation, continuous positive airway pressure or nasal intermittent positive pressure ventilation for postextubation respiratory support, when appropriate (1B).
Use of laryngeal mask for neonatal resuscitation in Brazil: A national survey
2023, Resuscitation Plus
The International Liaison Committee on Resuscitation suggests using the laryngeal mask airway (LMA) as an alternative to the face mask for performing positive pressure ventilation (PPV) in the delivery room in newborns ≥34 weeks. Because not much is known about the health professionals’ familiarity in using LMA in Brazil, this study aimed to describe the health professionals’ knowledge and practice of using LMA, who provide neonatal care in the country.
An online questionnaire containing 29 questions was sent to multi-healthcare professionals from different regions in the country through email and social media groups (WhatsApp®, Instagram®, Facebook®, ^and LinkedIn®). The participants anonymously answered the questions regarding their knowledge and expertise in using LMA to ventilate newborns in the delivery room.
We obtained 749 responses from all the regions in Brazil, with 80% from health professionals working in public hospitals. Most respondents were neonatologists (73%) having > 15 years of clinical practice. Among the respondents, 92% recognized the usefulness of LMA for performing PPV in newborns, 59% did not have specific training in LMA insertion, and only 8% reported that they have already used LMA in the delivery room. In 90% of the hospitals, no written protocol was available to use LMA; and in 68% of the hospitals, LMA was not available for immediate use.
This nationwide survey showed that most professionals recognize the usefulness of LMA. However, the device is scarcely available and underused in the routine of ventilatory assistance for newborns in delivery rooms in Brazil.
2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces
2022, Resuscitation
Citation Excerpt :
The full text of this CoSTR can be found on the ILCOR website.226 The SysRev identified 5 RCTs227–231 and 1 quasi-RCT232 involving a total of 1857 newborn infants and 2 retrospective cohort studies233,234 involving 218 newborn infants. An additional study235 reported secondary outcomes from a subset of newborn infants enrolled in an included RCT.228
This is the sixth annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. This summary addresses the most recently published resuscitation evidence reviewed by International Liaison Committee on Resuscitation Task Force science experts. Topics covered by systematic reviews include cardiopulmonary resuscitation during transport; approach to resuscitation after drowning; passive ventilation; minimising pauses during cardiopulmonary resuscitation; temperature management after cardiac arrest; use of diagnostic point-of-care ultrasound during cardiac arrest; use of vasopressin and corticosteroids during cardiac arrest; coronary angiography after cardiac arrest; public-access defibrillation devices for children; pediatric early warning systems; maintaining normal temperature immediately after birth; suctioning of amniotic fluid at birth; tactile stimulation for resuscitation immediately after birth; use of continuous positive airway pressure for respiratory distress at term birth; respiratory and heart rate monitoring in the delivery room; supraglottic airway use in neonates; prearrest prediction of in-hospital cardiac arrest mortality; basic life support training for likely rescuers of high-risk populations; effect of resuscitation team training; blended learning for life support training; training and recertification for resuscitation instructors; and recovery position for maintenance of breathing and prevention of cardiac arrest. Members from 6 task forces have assessed, discussed, and debated the quality of the evidence using Grading of Recommendations Assessment, Development, and Evaluation criteria and generated consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence-to-Decision Framework Highlights sections, and priority knowledge gaps for future research are listed.
Delivery mode and neonatal morbidity after remifentanil-PCA or epidural analgesia using the Ten Groups Classification System: A 5-year single-centre analysis of more than 10 000 deliveries
2022, European Journal of Obstetrics and Gynecology and Reproductive Biology
This study aimed to explore the potential association between remifentanil patient-controlled analgesia (RPCA) or epidural analgesia (EA), and caesarean section (CS) rate, operative vaginal delivery rate (OVD), operative delivery (OD) rate (CS or OVD) with pathological cardiotocography (CTG) tracing, Apgar score < 7 at 5 min after birth, incidence of perinatal asphyxia and neonatal intensive care unit (NICU) admission within four groups of the Ten Groups Classification System (TGCS) labour types; group 1: nulliparous, singleton cephalic, ≥37 weeks, spontaneous onset of labour; group 2a: nulliparous, singleton cephalic, ≥37 weeks, induction of labour; group 3: multiparous, singleton cephalic, ≥37 weeks, spontaneous onset of labour; group 4a: multipara, singleton cephalic, ≥37 weeks, induction of labour). We hypothesized that labour and delivery outcomes between RPCA and EA would differ within the different TGCS labour types.
10,561 deliveries (4876 with RPCA, 5685 with EA) at the University Clinical Centre Ljubljana, Slovenia, from 2015 through 2019 were analysed using the Slovenian National Perinatal Information System data.
Compared to EA, RPCA was associated with lower CS and OVD rates in nulliparous women with spontaneous onset of labour (group 1) (CS: 9.9 % vs14.3 %; P < 0.001) (OVD: 5.1 % vs 8.4 %; P < 0.001), in nulliparous women with induced labour (group 2a) (CS: 14.8 % vs 24.2 %; P < 0.001) (OVD: 6.5 % vs 8.9 %; P = 0.036) and in multiparous women with spontaneous onset of labour (group 3) (CS: 1.1 % vs 2.4 %; P = 0.021) (OVD: 0.1 % vs 0.8 %; P = 0.007), respectively. RPCA was associated with a lower incidence of OD with pathologic CTG in all four studied groups (groups 1, 2a, 3, 4a). No differences in APGAR < 7 at 5 min, neonatal asphyxia, and NICU admission were recorded between the two analgesic techniques within any of the TGCS groups.
Compared to EA, RPCA was not associated with worse delivery and neonatal outcomes within any of the four studied TGCS groups. RPCA could be used for labour analgesia routinely if strict adherence to protocols is ensured and regular staff training is provided.
One-rescuer newborn CPR using a face mask or an i-gel supraglottic airway and two-finger compressions – A manikin study with cross-over desgin
2022, Resuscitation Plus
Citation Excerpt :
A supraglottic airway is indicated when positive pressure ventilation with a face mask fails. Two clinical trials in late preterm and term infants reported lower rates of the need for endotracheal intubation with the use of a supraglottic airway compared to a face mask (8.5 vs 21.1%2 and 0.98% vs 15.85%3. Chest compressions are rarely needed, but are indicated if the heart rate responds poorly to effective ventilation.
When unanticipated neonatal asphyxia occurs, it may be necessary for a single resuscitator to commence advanced resuscitation before others arrive. We hypothesised that a single rescuer can provide positive pressure ventilations and chest compressions using higher inflation pressures and better adherence to the recommended compression rate with an i-gel supraglottic airway than with a face mask.
A manikin-based cross-over study was conducted. Twenty-one midwives performed both positive pressure ventilation using a T-piece and chest compressions with the two-finger technique on a newborn manikin alone. They performed ventilation with a face mask or an i-gel. The peak inspiratory pressure (PIP) was set to 30 cmH₂O. The actual PIPs were evaluated based on the values displayed on the manometer. The total amount of time taken to complete 30 cycles of three compressions and one ventilation was also evaluated.
The mean of the average PIP for each participant was significantly lower with a face mask than with an i-gel (17.3 ± 4.4 vs 28.2 ± 2.0 cmH₂O, p < 0.00001). The amount of time taken to complete 30 cycles was significantly longer with a face mask than with an i-gel (66.2 ± 6.1 vs 60.6 ± 3.4 seconds, p < 0.0001).
During one-rescuer newborn resuscitation using a T-piece and the two-finger technique, the PIPs are consistently high and 30 cycles of CPR are better adhered to 60 seconds using an i-gel.
Respiratory monitoring during neonatal resuscitation using a supraglottic airway device vs. a face mask
2022, Resuscitation
To evaluate the respiratory function of asphyxiated infants resuscitated with i-gel supraglottic airway (SGA) vs. face mask (FM) in a low-resource setting.
In this sub-study from the NeoSupra trial, respiratory function during the first 60 inflations was evaluated in 46 neonates (23 with SGA and 23 with FM) at the Mulago National Referral Hospital, Uganda. The primary outcome was the mask leak (%). The secondary outcomes included inspired (VTi) and expired (VTe) tidal volumes, and heart rate response to ventilation.
Median mask leak was 40% (IQR 22–52) with SGA and 39% (IQR 26–62) with FM (p = 0.38). Median VTe was 7.8 ml/kg (IQR 5.6–10.2) with SGA and 7.3 ml/kg (IQR 4.8–11.9) with FM (p = 0.84), while median VTi was 15.4 ml/kg (IQR 11–4-17.6) with SGA and 15.9 ml/kg (IQR 9.0–22.6) with FM (p = 0.68). A shorter time was needed to achieve heart rate > 100 bpm in SGA (median 13 s IQR 9–15) with respect to FM arm (median 61, IQR 33–140) (p = 0.0002).
Respiratory function was not statistically different between neonates resuscitated with SGA vs. FM. SGA was associated with faster heart rate recovery compared to FM in the subgroup of neonates with bradycardia. Further research is needed to investigate possible advantages of SGA on respiratory function at birth.

View all citing articles on Scopus

: Supported by a development program of the Autonomous Provence of Trento, Italy, implemented in Vietnam by the Association Amici della Neonatologia Trentina (Trento, Italy), in collaboration with East Meets West Foundation (Oakland, CA). Laryngeal Mask Airway Co (Teleflex, San Diego, CA) provided SLMA used in this study. The authors declare no conflicts of interest.

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Original ArticleSupreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial

Objective

Study design

Results

Conclusions

Trial Registration

Section snippets

Methods

Results

Discussion

Br J Anaesth

Resuscitation

Resuscitation

Resuscitation

Resuscitation

Resuscitation

Neonatal resuscitation: 2010 International consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations

Pediatrics

Neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care

Pediatrics

Endotracheal intubation attempts during neonatal resuscitation: success rates, duration, and adverse effects

Pediatrics

Intubation training in neonatal patients: a review of one trainee’s first 150 procedures

J Matern Fetal Neonatal Med

The laryngeal mask airway: potential application in neonates

Arch Dis Child Fetal Neonatal Ed

The advantages of the LMA over the tracheal tube or facemask: a meta-analysis

Can J Anaesth

Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications

Paediatr Anaesth

Original Article
Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial