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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu Aura-i size 1.5 | Experimental | patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight |
|
| air-Q size 1.5 | Experimental | patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight |
|
| Ambu Aura-i size 2 | Experimental | patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight |
|
| air-Q size 2 | Experimental | patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu Aura-i size 1.5 | Device | Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease and time to successful tracheal intubation | 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 | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ease and time to place airway | From picking up the airway device to bilateral chest expansion and presence of ETCO2 | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Number of attempts to place the supraglottic device and tracheal tube |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narasimhan Jagannathan, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Memorial Hospital | Chicago | Illinois | 60614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917058 | Background | Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. doi: 10.1111/j.1460-9592.2011.03703.x. Epub 2011 Sep 15. | |
| 21081777 | Background | Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2014 | |
| Reset | Mar 18, 2014 |
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| air-Q ILA size 1.5 | Device | Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed |
|
| Ambu Aura-i size 2 | Device | Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed |
|
| air-Q ILA size 2 | Device | Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed |
|
number of attempts needed for successful placement will be recorded (maximum of 3 attempts; >3 attempts will be considered as a failure) |
| participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Airway Leak Pressure | Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Fiberoptic grade of laryngeal view | The laryngeal alignment through the devices will be graded using an established scoring system | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Time to remove device | removal will be done with the use of a removal stylet. Should inadvertent extubation occur during removal of the device, the intubation will be deemed a failure. | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Airway maneuvers | The number and type of various airway maneuvers such as jaw thrust, neck extension, advancement/ withdrawal of the supraglottic device, and/ or anterior Laryngeal Pressure to optimize tracheal intubation will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Adverse effects | complications such as oxygen desaturations, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded | Participants will be followed for the duration of anesthesia and 24 hours postoperatively |
| 21973052 | Background | Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x. |
| 20716075 | Background | Baker PA, Brunette KE, Byrnes CA, Thompson JM. A prospective randomized trial comparing supraglottic airways for flexible bronchoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):831-8. doi: 10.1111/j.1460-9592.2010.03362.x. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2014 | Mar 18, 2014 |