Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children
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ClinicalTrials.gov Identifier: NCT02189590 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : October 24, 2014
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Condition or disease | Intervention/treatment | Phase |
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Tracheal Intubation in Children | Device: i-gel Device: air-Q | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Care Provider) |
Official Title: | A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
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Experimental: air-Q
Patients will receive the air-Q with size based on manufacturer recommendations of body weight
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Device: air-Q
Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed. |
Experimental: i-gel
Patients will receive the i-gel with size based on manufacturer recommendations of body weight
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Device: i-gel
Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed. |
- 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 ]Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation
- Ease of Placement of Supraglottic Airway [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]Ease of placement of supraglottic device ranging from 1 (easy) to 4 (difficult).
- Number of Attempts to Place the Supraglottic Device [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]Number of attempts will be limited to 3
- Supraglottic Airway Leak Pressure [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]The airway pressure at which an airway leak is observed after placement of the supraglottic airway
- Fiberoptic Grade of Laryngeal View [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system
- Airway Maneuvers [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]The number and type of airway maneuvers performed during tracheal intubation will be recorded
- Postoperative Complications [ Time Frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively ]Complications noted postoperatively relating to the airway, such as sore throat or hoarseness.
- Time to Placement of Supraglottic Airway [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]Time to placement of supraglottic device will be measured.
- Number of Attempts to Place the Tracheal Tube [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3

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Ages Eligible for Study: | 1 Month to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Children undergoing general anesthesia requiring tracheal intubation
- Age one month to six years
Exclusion Criteria:
- ASA class IV, V
- Children receiving emergent surgery
- History or high suspicion of a difficult airway
- Active upper respiratory tract infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189590
United States, Illinois | |
Anne & Robert H. Lurie Children's Hospital of Chicago | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Narasimhan Jagannathan, MD | Ann & Robert H Lurie Children's Hospital of Chicago / Stanley Manne Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Narasimhan Jagannathan, Primary Investigator; MD, Ann & Robert H Lurie Children's Hospital of Chicago |
ClinicalTrials.gov Identifier: | NCT02189590 |
Other Study ID Numbers: |
I-gel versus air-Q |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | October 24, 2014 |
Last Verified: | October 2014 |
supraglottic airway children fiberoptic guided tracheal intubation air-Q i-gel |