Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2012 by Olga Plattner, Medical University of Vienna.
Recruitment status was: Recruiting

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

Purpose

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	Intervention
Infants Difficult Airway	Other: laryngoscopy with oxygen Other: laryngoscopy without oxygen


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy

Genetic and Rare Diseases Information Center resources: Pierre Robin Sequence Chromosomal Triplication

U.S. FDA Resources

Further study details as provided by Olga Plattner, Medical University of Vienna:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	48
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664234

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


Responsible Party:	Olga Plattner, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01664234 History of Changes
Other Study ID Numbers:	ECS 1178/2012
Study First Received:	August 10, 2012
Last Updated:	August 10, 2012

Keywords provided by Olga Plattner, Medical University of Vienna:


infants with cleft palate Pierre Robin Treacher Collins trisomy 21

ClinicalTrials.gov processed this record on September 21, 2017

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