- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01664234
Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
August 30, 2023 updated by: Olga Plattner, Medical University of Vienna
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olga Plattner, M.D.
- Phone Number: 431404002248
- Email: olga.plattner@meduniwien.ac.at
Study Locations
-
-
Borschkegasse
-
Vienna, Borschkegasse, Austria, 1090
- Medizinischen Universität Wien
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olga Plattner, M.D., Medizinischen Universität Wien Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
December 30, 2014
Study Completion (Actual)
December 30, 2014
Study Registration Dates
First Submitted
August 10, 2012
First Submitted That Met QC Criteria
August 10, 2012
First Posted (Estimated)
August 14, 2012
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ECS 1178/2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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