Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by 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 Blind (Subject)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
infants with cleft palate
Pierre Robin
Treacher Collins
trisomy 21

ClinicalTrials.gov processed this record on October 19, 2014