Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, time for device removal after intubation, and peri-operative complications will also be assessed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: air-Q Patients will receive the air-Q with size based on manufacturer recommendations of body weight |
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 |
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.
|
Outcome Measures
Primary Outcome Measures
- Time to Successful Tracheal Intubation [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
Secondary Outcome Measures
- Ease of Placement of Supraglottic Airway [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 [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 [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 [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 [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 [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 [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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children undergoing general anesthesia requiring tracheal intubation
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Age one month to six years
Exclusion Criteria:
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ASA class IV, V
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Children receiving emergent surgery
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History or high suspicion of a difficult airway
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Active upper respiratory tract infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anne & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
- Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert H Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Abukawa Y, Hiroki K, Ozaki M. Initial experience of the i-gel supraglottic airway by the residents in pediatric patients. J Anesth. 2012 Jun;26(3):357-61. doi: 10.1007/s00540-011-1322-1. Epub 2012 Feb 7.
- Emmerich M, Tiesmeier J. The I-gel supraglottic airway: a useful tool in case of difficult fiberoptic intubation. Minerva Anestesiol. 2012 Oct;78(10):1169-70.
- Foucher-Lezla A, Lehousse T, Monrigal JP, Granry JC, Beydon L. Fibreoptic assessment of laryngeal positioning of the paediatric supraglottic airway device I-Gel. Eur J Anaesthesiol. 2013 Jul;30(7):441-2. doi: 10.1097/EJA.0b013e32835f9969.
- Hughes C, Place K, Berg S, Mason D. A clinical evaluation of the I-gel ™ supraglottic airway device in children. Paediatr Anaesth. 2012 Aug;22(8):765-71. doi: 10.1111/j.1460-9592.2012.03893.x. Epub 2012 Jun 1.
- Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu ® Aura-i ™ with the air-Q ™ intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.
- Jagannathan N, Sommers K, Sohn LE, Sawardekar A, Shah RD, Mukherji II, Miller S, Voronov P, Seraphin S. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children. Paediatr Anaesth. 2013 Feb;23(2):127-33. doi: 10.1111/pan.12078. Epub 2012 Nov 27.
- Kim MS, Oh JT, Min JY, Lee KH, Lee JR. A randomised comparison of the i-gel™ and the Laryngeal Mask Airway Classic™ in infants. Anaesthesia. 2014 Apr;69(4):362-7. doi: 10.1111/anae.12592.
- Kim YL, Seo DM, Shim KS, Kim EJ, Lee JH, Lee SG, Ban JS. Successful tracheal intubation using fiberoptic bronchoscope via an I-gel™ supraglottic airway in a pediatric patient with Goldenhar syndrome -A case report-. Korean J Anesthesiol. 2013 Jul;65(1):61-5. doi: 10.4097/kjae.2013.65.1.61. Epub 2013 Jul 19.
- Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique™ and Classic™ in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.
- Park C, Bahk JH, Ahn WS, Do SH, Lee KH. The laryngeal mask airway in infants and children. Can J Anaesth. 2001 Apr;48(4):413-7.
- Sohn LE, Jagannathan N, Sequera-Ramos L, Sawardekar A, Schaldenbrand K, De Oliveira GS. A randomised comparison of free-handed vs air-Q assisted fibreoptic-guided tracheal intubation in children < 2 years of age. Anaesthesia. 2014 Jul;69(7):723-8. doi: 10.1111/anae.12667. Epub 2014 May 2.
- Timmermann A. Supraglottic airways in difficult airway management: successes, failures, use and misuse. Anaesthesia. 2011 Dec;66 Suppl 2:45-56. doi: 10.1111/j.1365-2044.2011.06934.x. Review.
- I-gel versus air-Q