Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children
This study has been completed.
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01535742
First received: February 13, 2012
Last updated: June 27, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 13, 2012 | ||||
| Last Updated Date | June 27, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ease and time to successful tracheal intubation [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ] from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01535742 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children | ||||
| Official Title ICMJE | Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children | ||||
| Brief Summary | The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA. |
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| Detailed Description | The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) |
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| Condition ICMJE | Tracheal Intubation in Children | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month to 6 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01535742 | ||||
| Other Study ID Numbers ICMJE | Air-Q versus Ambu-Aura-i | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago | ||||
| Study Sponsor ICMJE | Ann & Robert H Lurie Children's Hospital of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ann & Robert H Lurie Children's Hospital of Chicago | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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