Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children

• ClinicalTrials.gov Identifier: NCT02189590
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: October 24, 2014
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Information provided by (Responsible Party): Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

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
Tracheal Intubation in Children	Device: i-gel; Device: air-Q	Not Applicable

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

• 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

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 :

1. 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

Secondary Outcome Measures :

1. 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).
2. 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
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
4. 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
5. 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
6. 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.
7. 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.
8. 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

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Illinois

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

More Information

Publications:

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.

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.

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.

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.

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, 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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: October 24, 2014
• Last Verified: October 2014

Keywords provided by Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago:

supraglottic airway; children; fiberoptic guided tracheal intubation; air-Q; i-gel