ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01664234
Recruitment Status : Unknown
Verified August 2012 by Olga Plattner, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Olga Plattner, Medical University of Vienna

Study Description
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page 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    Key Record Dates
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