Comparison Between the Fastrach and CTrach Laryngeal Mask Airway
This study has been terminated.
(recruitment challenges, device no longer available)
Sponsor:
Outcomes Research Consortium
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00814775
First received: December 23, 2008
Last updated: September 3, 2010
Last verified: September 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 23, 2008 | ||||||||
| Last Updated Date | September 3, 2010 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To compare the time required for successful intubation between the Fastrach and CTrach LMA devices in patients with a Mallampati score III and IV without use of fiberoptic bronchoscopy [ Time Frame: 60 seconds ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00814775 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To gather pilot information that may determine if five airway risk predictors correlate with difficult ventilation or intubation, using these airway devices [ Time Frame: 60 seconds ] [ Designated as safety issue: No ] | ||||||||
| 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 | Comparison Between the Fastrach and CTrach Laryngeal Mask Airway | ||||||||
| Official Title ICMJE | Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4 | ||||||||
| Brief Summary | The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult. |
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| Detailed Description | Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices. Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Intubation | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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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 | Terminated | ||||||||
| Enrollment ICMJE | 43 | ||||||||
| Completion Date | June 2010 | ||||||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00814775 | ||||||||
| Other Study ID Numbers ICMJE | 08-358 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Marco Maurtua, M.D., Cleveland Clinic | ||||||||
| Study Sponsor ICMJE | Outcomes Research Consortium | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Outcomes Research Consortium | ||||||||
| Verification Date | September 2010 | ||||||||
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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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