Clinical trial NCT02189590: Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children
Official title: A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation in Children
Keywords: supraglottic airway
children
fiberoptic guided tracheal intubation
air-Q
i-gel
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 96
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Successful Tracheal Intubation
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes:
measure: Ease of Placement of Supraglottic Airway
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Number of Attempts to Place the Supraglottic Device
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Supraglottic Airway Leak Pressure
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Fiberoptic Grade of Laryngeal View
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Airway Maneuvers
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Postoperative Complications
timeFrame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
measure: Time to Placement of Supraglottic Airway
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Number of Attempts to Place the Tracheal Tube
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Anne & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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. No abstract available.
citation: 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.
citation: 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.
citation: 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. No abstract available.
citation: 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.
citation: 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.
citation: Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) 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.
citation: 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. doi: 10.1007/BF03014975.
citation: Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24.