SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-52
SponsorVinícius C Quintão, MD, MSc, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Apneic oxygenation
Procedure/Surgery1 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: Apneic oxygenationExperimental treatment 1 intervention
Trial outcomes
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
Time frame
From randomization until up to 15 minutesSecondary outcomes
1
Desaturation rate
Occurrence and duration of moderate and severe desaturation (SpO2 \< 90% and SpO2 \< 80%), with or without bradycardia, during intubation.
Time frame
From randomization until up to 15 minutes2
Overall number of intubation attempts
The overall number of intubation attempts.
Time frame
From randomization until up to 15 minutes3
Time to intubation
Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography).
Time frame
From randomization until up to 5 minutes4
Respiratory complications rate
Respiratory complications and complications of airway management within the first 24 hours, such as airway injury, cardiopulmonary resuscitation, bleeding, aspiration of gastric contents, post-extubation stridor, laryngospasm, bronchospasm, need for High Flow Nasal Oxygen (if not preoperatively on oxygen), need for low flow nasal oxygen (if not preoperatively on oxygen) or need for re-intubation will be recorded. Respiratory complications are defined as the need for re-intubation after being extubated, persistent stridor (even if oxygen is not required), respiratory failure, the occurrence of pneumothorax, or the need for any additional diagnostic examination following respiratory problems (i.e., bronchoscopy, radiology).
Time frame
From randomization until up to 24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vinícius C Quintão, MD, MSc, PhD
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
University of Bern
Collaborator
The University of Western Australia
Collaborator
Source ClinicalTrials.gov