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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laryngoscopy with simultaneous insufflation of oxygen | Experimental | 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. |
|
| laryngoscopy without simultaneous oxygen insufflation | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laryngoscopy with oxygen | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Plattner, M.D. | Medizinischen Universität Wien Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinischen Universität Wien | Vienna | Borschkegasse | 1090 | Austria |
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| ID | Term |
|---|---|
| D010855 | Pierre Robin Syndrome |
| D008342 | Mandibulofacial Dysostosis |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| ID | Term |
|---|---|
| D007828 | Laryngoscopy |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| laryngoscopy without oxygen | Other | Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute. |
|
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003394 | Craniofacial Dysostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D003103 | Coloboma |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |