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LaryngOscoPy for neonaTal and Infant aIrway Management wIth Supplemental oxygEn
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 1 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-12-01
Primary completion: 2026-06-01
Study completion finish: 2026-12-01
Study type
PREVENTION
Phase
NA
Trial ID
NCT06683599
Intervention or treatment
PROCEDURE: Apneic oxygenation
Conditions
- • Difficult Airway
- • Difficult Airway Intubation
- • Neonate
Find a site
Closest Location:
Perth Children's Hospital
Research sites nearby
Select from list below to view details:
Perth Children's Hospital
Perth, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
NO_INTERVENTION: Standard of care
| Not specified |
EXPERIMENTAL: Apneic oxygenation
| PROCEDURE: Apneic oxygenation
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Desaturation rate | Occurrence and duration of moderate and severe desaturation (SpO2 \< 90% and SpO2 \< 80%), with or without bradycardia, during intubation. | From randomization until up to 15 minutes |
| Overall number of intubation attempts | The overall number of intubation attempts. | From randomization until up to 15 minutes |
| 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). | From randomization until up to 5 minutes |
| 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). | From randomization until up to 24 hours |
| First EtCO2 after successful intubation | Value in mmHg or kPa of the first reliable etCO2 reading after successful intubation | From randomization until up to 10 minutes |
| Cormack-Lehane score | The Cormack-Lehane score, classified as 1, 2a, 2b, 3, or 4, recorded at each laryngoscopy attempt | From randomization until up to 5 minutes |
| The need for additional devices | The need for additional devices used at any step of intubation | From randomization until up to 5 minutes |
| Duration of severe desaturation | Duration of moderate and severe desaturation (SpO2 \< 80%), with or without bradycardia, during intubation | From randomization until up to 15 minutes |
| Percentage of Glottic Opening (POGO) score | Percentage of Glottic Opening (POGO) score recorded at each laryngoscopy attempt, ranging from 0% to 100%, with 100% indicating the best possible glottic view | From randomization until up to 5 minutes |
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