Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
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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
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Condition or disease | Intervention/treatment | Phase |
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Infants Difficult Airway | Other: laryngoscopy with oxygen Other: laryngoscopy without oxygen | Not Applicable |
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 |

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.
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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.
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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.
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Other: laryngoscopy without oxygen
Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
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- 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.
- 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

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Ages Eligible for Study: | 1 Month to 2 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Olga Plattner, M.D. | 431404002248 | olga.plattner@meduniwien.ac.at |
Austria | |
Medizinischen Universität Wien | Recruiting |
Vienna, Borschkegasse, Austria, 1090 | |
Contact: Olga Plattner, M.D. 431404002248 olga.plattner@meduniwien.ac.at |
Principal Investigator: | Olga Plattner, M.D. | Medizinischen Universität Wien Vienna |
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 |