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

NCT06683599 | Recruiting

• 1 other identifier: SEALION
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Difficult Airway; Difficult Airway Intubation; Neonate

Keywords

Difficult intubation; Apneic oxygenation; Neonate

Outcome Measures

Primary Outcomes (1)

• First-attempt success rate

  The primary study outcome is to evaluate the first attempt success rate of oral tracheal intubation without desaturation (\< 90%) and/or bradycardia (\< 100 bpm) with video laryngoscope with supplemental oxygen (apneic oxygenation) vs without supplemental oxygen in infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography suggesting correct ETT placement and auscultation of breath sounds in the lungs

  From randomization until up to 15 minutes

Secondary Outcomes (9)

• Desaturation rate

  From randomization until up to 15 minutes

• Overall number of intubation attempts

  From randomization until up to 15 minutes

• Time to intubation

  From randomization until up to 5 minutes

• Respiratory complications rate

  From randomization until up to 24 hours

• First EtCO2 after successful intubation

  From randomization until up to 10 minutes

Study Arms (2)

Standard of care

NO INTERVENTION

Tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1 without apneic oxygenation.

Apneic oxygenation

EXPERIMENTAL

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.

Procedure: Apneic oxygenation

Interventions

Apneic oxygenation PROCEDURE

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.

Apneic oxygenation

Eligibility Criteria

• Age: 1 Minute - 52 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vinícius C Quintão, MD, MSc, PhD: lead
• University of Bern: collaborator
• The University of Western Australia: collaborator

Study Sites (3)

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

Hospital das Clinicas HCFMUSP

São Paulo, 05403000, Brazil

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Related Publications (11)

• 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/jama.2018.3708.

  PMID: 29715354 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1097/PCC.0b013e3181fe472d.

  PMID: 21057359 BACKGROUND

• 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 BACKGROUND

• Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.

  PMID: 26705976 BACKGROUND

• Disma N, Virag K, Riva T, Kaufmann J, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; AUSTRIA (Maria Vittinghoff); BELGIUM (Francis Veyckemans); CROATIA (Sandra Kralik); CZECH REPUBLIC (Jiri Zurek); DENMARK (Tom Hansen); ESTONIA (Reet Kikas); FINLAND (Tuula Manner); FRANCE (Christophe Dadure, Anne Lafargue); GERMANY (Karin Becke, Claudia Hoehne); GREECE (Anna Malisiova); HUNGARY (Andrea Szekely); IRELAND (Brendan O'Hare); ITALY (Nicola Disma); LATVIA (Zane Straume); LITHUANIA (Laura Lukosiene); LUXEMBOURG (Bernd Schmitz); MALTA (Francis Borg); NETHERLANDS (Jurgen de Graaff); NORWAY (Wenche B Boerke); POLAND (Marzena Zielinska); PORTUGAL (Maria Domingas Patuleia); ROMANIA (Radu Tabacaru); SERBIA (Dusica Simic); SLOVAKIA (Miloslav Hanula); SLOVENIA (Jelena Berger); SPAIN (Ignacio Galvez Escalera); SWEDEN (Albert Castellheim); SWITZERLAND (Walid Habre); TURKEY (Dilek Ozcengiz - Zehra Hatipoglu); UKRAINE (Dmytro Dmytriiev); UNITED KINGDOM (Thomas Engelhardt, Suellen Walker); Management Team. Difficult tracheal intubation in neonates and infants. NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study. Br J Anaesth. 2021 Jun;126(6):1173-1181. doi: 10.1016/j.bja.2021.02.021. Epub 2021 Apr 1.

  PMID: 33812665 BACKGROUND

• Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.

  PMID: 35476651 BACKGROUND

Study Officials

• Vinicius C Quintao, MD, MSc, PhD

  Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinicius C Quintao, MD, MSc, PhD

CONTACT

+ 55 11 97127-3950; vinicius.quintao@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); SE (1); AU (1)