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

NCT02189590 | Completed

• 1 other identifier: I-gel versus air-Q
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Intubation in Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to Successful Tracheal Intubation

  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

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcomes (8)

• Ease of Placement of Supraglottic Airway

  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

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Supraglottic Airway Leak Pressure

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Fiberoptic Grade of Laryngeal View

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

• Airway Maneuvers

  participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Study Arms (2)

air-Q

EXPERIMENTAL

Patients will receive the air-Q with size based on manufacturer recommendations of body weight

Device: air-Q

i-gel

EXPERIMENTAL

Patients will receive the i-gel with size based on manufacturer recommendations of body weight

Device: i-gel

Interventions

i-gel DEVICE

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.

i-gel

air-Q DEVICE

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.

air-Q

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children undergoing general anesthesia requiring tracheal intubation
• Age one month to six years

You may not qualify if:

• ASA class IV, V
• Children receiving emergent surgery
• History or high suspicion of a difficult airway
• Active upper respiratory tract infection

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Anne & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (13)

• 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.

  PMID: 22074079 BACKGROUND

• 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.

  PMID: 24797607 BACKGROUND

• 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.

  PMID: 24126262 BACKGROUND

• 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.

  PMID: 22310833 BACKGROUND

• 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.

  PMID: 23571478 BACKGROUND

• 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.

  PMID: 22672411 BACKGROUND

• 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.

  PMID: 23189931 BACKGROUND

• 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.

  PMID: 23059523 BACKGROUND

• 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.

  PMID: 23904941 BACKGROUND

• 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.

  PMID: 24641642 BACKGROUND

• 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.

  PMID: 22971118 BACKGROUND

• 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.

  PMID: 11339788 BACKGROUND

• 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.

  PMID: 25537736 DERIVED

Study Officials

• Narasimhan Jagannathan, MD

  Ann & Robert H Lurie Children's Hospital of Chicago / Stanley Manne Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator; MD

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

US (1)