SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation

Официальное название

SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula

Обзор

Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \<80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time. This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.

Подробное описание

Eligible children will undergo preparation for intubation following the local Standard Operating Procedures (SOPs) of the pediatric anesthesia departments. Mandatory monitoring includes pulse oximetry (SpO2), heart rate (HR), and non-invasive blood pressure (NIBP).

Anesthesia Induction:

Where feasible, all children enrolled in this protocol will be pre-oxygenated for one minute prior to induction of anesthesia using a face mask with FiO2 1.0 and a flow rate of 6-10 L/min. Anesthesia induction for tracheal intubation will involve a combination of sedative or hypnotic drugs, opioids, and a non-depolarizing muscle relaxant.

Required Medications (per protocol):

Neuromuscular Blocking Agent (NMBA): One of the following-Rocuronium 0.5-1 mg/kg, Cis-Atracurium 0.2-0.5 mg/kg, Atracurium 0.5 mg/kg, Vecuronium 0.1 mg/kg, Mivacurium 0.2-0.3 mg/kg, or Succinylcholine 2 mg/kg.

Hypnotic Agent: One or more of the following-Thiopentone 4-7 mg/kg, Ketamine 0.5-2 mg/kg, Propofol 1-4 mg/kg, Midazolam 0.5-1 mg/kg, or Sevoflurane up to 8%.

Optional Medications: An opioid and/or anticholinergic may be administered at the anesthetist's discretion.

Pre-Intubation Preparation:

Following induction of anesthesia and administration of an NMBA, bag-mask ventilation with FiO2 1.0 (flow rate of 6-10 L/min) will be performed for 60 seconds until apnea occurs. To facilitate airway management, complete neuromuscular blockade will be confirmed using train-of-four (TOF) monitoring. Oxygen administration, laryngoscopy, and tracheal intubation will follow.

Intubation Procedure:

Oxygen administration during intubation is mandatory for all participants and will be randomized as follows:

Apneic Oxygenation: Oxygen will be administered at 1 L/kg/min via a conventional nasal cannula. Laryngoscopy and tracheal intubation will proceed following apneic oxygenation.

Standard Care: No apneic oxygenation will be administered. After induction, laryngoscopy and tracheal intubation will proceed without additional oxygen support.

Tube Selection:

For premature neonates under 1 kg, an uncuffed tube with an internal diameter (ID) of 2.5 will be used.

For premature neonates and newborns between 1 kg and 3.0 kg, an uncuffed tube with ID 3.0 will be used.

For babies over 3.0 kg up to 8 months, a cuffed tube with ID 3.0 or an uncuffed tube with ID 3.5 will be used.

For infants aged 8 to 12 months, a cuffed tube with ID 3.5 or an uncuffed tube with ID 4.0 will be used.

Oxygen delivery will follow the assigned randomization group, either via conventional nasal cannula (apneic oxygenation) or standard care.

Laryngoscope Blade Selection:

For children weighing less than 1 kg, a Miller or Macintosh blade, size No. 0, will be used. In cases of unexpected difficult intubation, the difficult airway algorithm will be applied. After an unsuccessful first intubation attempt with the assigned flow rate, clinical judgment will guide the intubating physician on whether to repeat the attempt with the same flow rate or to modify the flow rate, blade size, or type of laryngoscope. A maximum of four intubation attempts will be allowed, with the final attempt performed by the most experienced physician present. Additional tools, such as a stylet or bougie, may be used at any stage. If intubation remains unsuccessful, the difficult airway algorithm will be applied, and a supraglottic airway (SGA) device will be inserted.

Вмешательства

• Процедура Apneic oxygenation
  1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.

Первичные конечные точки

• First-attempt success rate [Срок оценки: From randomization until up to 15 minutes]

Вторичные конечные точки (9)

• Desaturation rate [Срок оценки: From randomization until up to 15 minutes]
• Overall number of intubation attempts [Срок оценки: From randomization until up to 15 minutes]
• Time to intubation [Срок оценки: From randomization until up to 5 minutes]
• Respiratory complications rate [Срок оценки: From randomization until up to 24 hours]
• First EtCO2 after successful intubation [Срок оценки: From randomization until up to 10 minutes]
• Cormack-Lehane score [Срок оценки: From randomization until up to 5 minutes]
• The need for additional devices [Срок оценки: From randomization until up to 5 minutes]
• Duration of severe desaturation [Срок оценки: From randomization until up to 15 minutes]
• Percentage of Glottic Opening (POGO) score [Срок оценки: From randomization until up to 5 minutes]

Критерии участия

Критерии включения

• Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.
• Neonates and infants up to 52 weeks post-conceptual age.
• Written informed consent provided by legal guardians prior to the intervention.

Критерии исключения

• Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.
• Requirement for an alternative technique to direct laryngoscopy to secure the airway.
• Specific conditions, such as congenital heart disease requiring FiO₂ < 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Австралия · 1 центр

• Perth Children's Hospital — Perth

Бразилия · 1 центр

• Hospital das Clinicas HCFMUSP — São Paulo

Швеция · 1 центр

• Uppsala University Hospital — Uppsala

Публикации

• Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/ PMID 29715354
• Patel R, Lenczyk M, Hannallah RS, McGill WA. Age and the onset of desaturation in apnoeic children. Can J Anaesth. 1994 Sep;41(9):771-4. doi: 10.1007/BF03011582. PMID 7954992
• Hardman JG, Wills JS. The development of hypoxaemia during apnoea in children: a computational modelling investigation. Br J Anaesth. 2006 Oct;97(4):564-70. doi: 10.1093/bja/ael178. Epub 2006 Jul 27. PMID 16873387
• Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007. PMID 7856895
• Shiima Y, Berg RA, Bogner HR, Morales KH, Nadkarni VM, Nishisaki A; National Emergency Airway Registry for Children Investigators. Cardiac Arrests Associated With Tracheal Intubations in PICUs: A Multicenter Cohort Study. Crit Care Med. 2016 Sep;44(9):1675-82. doi: 10.1097/CCM.0000000000001741. PMID 27071070
• Stinson HR, Srinivasan V, Topjian AA, Sutton RM, Nadkarni VM, Berg RA, Raymond TT; American Heart Association Get With the Guidelines-Resuscitation Investigators. Failure of Invasive Airway Placement on the First Attempt Is Associated With Progression to Cardiac Arrest in Pediatric Acute Respiratory Compromise. Pediatr Crit Care Med. 2018 Jan;19(1):9-16. doi: 10.1097/PCC.0000000000001370. PMID 29135805
• Nishisaki A, Ferry S, Colborn S, DeFalco C, Dominguez T, Brown CA 3rd, Helfaer MA, Berg RA, Walls RM, Nadkarni VM; National Emergency Airway Registry (NEAR); National Emergency Airway Registry for kids (NEAR4KIDS) Investigators. Characterization of tracheal intubation process of care and safety outcomes in a tertiary pediatric intensive care unit. Pediatr Crit Care Med. 2012 Jan;13(1):e5-10. doi: PMID 21057359
• Khemani RG, Markovitz BP, Curley MAQ. Characteristics of children intubated and mechanically ventilated in 16 PICUs. Chest. 2009 Sep;136(3):765-771. doi: 10.1378/chest.09-0207. Epub 2009 Jun 19. PMID 19542258

Идентификаторы

NCT: NCT06683599 · SEALION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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