Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

This study is currently recruiting participants.

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

Tracking Information

First Received Date ^ICMJE

August 10, 2012

Last Updated Date

August 10, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Condition ^ICMJE

Infants
Difficult Airway

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 2 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Olga Plattner, M.D.

431404002248

olga.plattner@meduniwien.ac.at

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01664234

Other Study ID Numbers ^ICMJE

ECS 1178/2012

Has Data Monitoring Committee

Responsible Party

Olga Plattner, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Olga Plattner, M.D.

Medizinischen Universität Wien Vienna

Information Provided By

Medical University of Vienna

Verification Date

August 2012

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

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