Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Study Overview
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Brief Summary
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Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.

Conditions
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Infants, Difficult Airway

Intervention / Treatment
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* Other: laryngoscopy with oxygen
* Other: laryngoscopy without oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants (0-2) difficult airways Exclusion Criteria: . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laryngoscopy with simultaneous insufflation of oxygen<br>Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. | Other: laryngoscopy with oxygen<br>* Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.<br>|
| Placebo Comparator: laryngoscopy without simultaneous oxygen insufflation<br>Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. | Other: laryngoscopy without oxygen<br>* Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to oxygen saturation | The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean oxygenation comparison | Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21