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
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
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
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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:
Genetics Home Reference related topics:
Treacher Collins syndrome
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 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 (Child) |
| 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
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 |
| 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 September 26, 2016