LaryngOscoPy for neonaTal and Infant aIrway Management wIth Supplemental oxygEn

Not Applicable

Recruiting

• Conditions: Difficult Airway; Difficult Airway Intubation; Neonate

• Registration Number: NCT06683599
• Lead Sponsor: Vinícius C Quintão, MD, MSc, PhD

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Status Verified: 2024-12
• Study Start: 2024-12-10
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First-attempt success rate	From randomization until up to 15 minutes	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

Secondary Outcome Measures

Name	Time	Method
Desaturation rate	From randomization until up to 15 minutes	Occurrence and duration of moderate and severe desaturation (SpO2 \< 90% and SpO2 \< 80%), with or without bradycardia, during intubation.
Overall number of intubation attempts	From randomization until up to 15 minutes	The overall number of intubation attempts.
Time to intubation	From randomization until up to 5 minutes	Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography).
Respiratory complications rate	From randomization until up to 24 hours	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).
First EtCO2 after successful intubation	From randomization until up to 10 minutes	Value in mmHg or kPa of the first reliable etCO2 reading after successful intubation
Cormack-Lehane score	From randomization until up to 5 minutes	The Cormack-Lehane score, classified as 1, 2a, 2b, 3, or 4, recorded at each laryngoscopy attempt
The need for additional devices	From randomization until up to 5 minutes	The need for additional devices used at any step of intubation
Duration of severe desaturation	From randomization until up to 15 minutes	Duration of moderate and severe desaturation (SpO2 \< 80%), with or without bradycardia, during intubation
Percentage of Glottic Opening (POGO) score	From randomization until up to 5 minutes	Percentage of Glottic Opening (POGO) score recorded at each laryngoscopy attempt, ranging from 0% to 100%, with 100% indicating the best possible glottic view

Trial Locations

Locations (2)

Perth Children's Hospital; 🇦🇺 Perth, Western Australia, Australia

Hospital das Clinicas HCFMUSP; 🇧🇷 Sao Paulo, Brazil