Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Infants; Difficult Airway	Other: laryngoscopy with oxygen; Other: laryngoscopy without oxygen	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Supportive Care
Study Start Date :	August 2012
Estimated Primary Completion Date :	August 2013
Estimated Study Completion Date :	August 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.	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.
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.	Other: laryngoscopy without oxygen; Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	1 Month to 2 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Olga Plattner, M.D.	431404002248	olga.plattner@meduniwien.ac.at

Locations

Austria
Medizinischen Universität Wien	Recruiting
Vienna, Borschkegasse, Austria, 1090
Contact: Olga Plattner, M.D. 431404002248 olga.plattner@meduniwien.ac.at

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:	Olga Plattner, M.D.	Medizinischen Universität Wien Vienna

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Olga Plattner, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01664234 History of Changes
Other Study ID Numbers:	ECS 1178/2012
First Posted:	August 14, 2012
Last Update Posted:	August 14, 2012
Last Verified:	August 2012

Keywords provided by Olga Plattner, Medical University of Vienna:

infants with cleft palate; Pierre Robin; Treacher Collins; trisomy 21