Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Olga Plattner, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01664234
First received: August 10, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

August 10, 2012
August 10, 2012
August 2012
August 2013   (final data collection date for primary outcome measure)
time to oxygen saturation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
mean oxygenation comparison [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test
Same as current
Not Provided
Not Provided
 
Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Infants
  • Difficult Airway
  • Other: laryngoscopy with oxygen
    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
    Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
  • Experimental: laryngoscopy with simultaneous insufflation of oxygen
    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.
    Intervention: Other: laryngoscopy with oxygen
  • Placebo Comparator: laryngoscopy without simultaneous oxygen insufflation
    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.
    Intervention: Other: laryngoscopy without oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
1 Month to 2 Years
No
Contact: Olga Plattner, M.D. 431404002248 olga.plattner@meduniwien.ac.at
Austria
 
NCT01664234
ECS 1178/2012
No
Olga Plattner, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Olga Plattner, M.D. Medizinischen Universität Wien Vienna
Medical University of Vienna
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP