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recruitment challenges, device no longer available
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Fastrach Laryngeal Mask Airway intubation |
|
| Group 2 | Active Comparator | Intubation of difficult airway using CTrach Laryngeal Mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fastrach Laryngeal Mask | Device | Intubation of difficult airway using Fastrach Laryngeal Mask |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from start of intubation to successfully intubated | |
| To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy | 60 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Maurtua, MD | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fastrach | Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask |
| FG001 | CTrach | Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fastrach | Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask |
| BG001 | CTrach | Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | seconds | from start of intubation to successfully intubated |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fastrach | Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Johnson | Cleveland Clinic | 216-444-9950 | johnsor13@ccf.org |
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| CTrach Laryngeal Mask |
| Device |
CTrach Laryngeal Mask intubation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy | Posted | Median | Inter-Quartile Range | seconds | 60 seconds |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | CTrach | Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation | 0 | 20 | 0 | 20 |
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