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OpenTrials
Completed

NCT Number: NCT01664234

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

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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Key information

Conditions

Infants Abnormalities, Multiple Bone Diseases Bone Diseases, Developmental Chromosome Disorders Coloboma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniofacial Dysostosis Difficult Airway Down Syndrome Dysostoses Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Intellectual Disability Jaw Abnormalities Jaw Diseases Mandibulofacial Dysostosis Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pierre Robin Syndrome Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinischen Universität Wien

Vienna, Borschkegasse, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

laryngoscopy without oxygen

Other

Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.

Primary outcomes

  1. time to oxygen saturation

    Time frame: Day 1

    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.

Secondary outcomes

  1. mean oxygenation comparison

    Time frame: Day 1

    Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2012
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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