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

NCT ID: NCT02189590

Last Updated: 2014-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Tracheal Intubation in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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air-Q

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

Group Type EXPERIMENTAL

air-Q

Intervention Type 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.

i-gel

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

Group Type EXPERIMENTAL

i-gel

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Narasimhan Jagannathan

Primary Investigator; MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Narasimhan Jagannathan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22074079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24797607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24126262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22310833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23571478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22672411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23189931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23059523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23904941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24641642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22971118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11339788 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25537736 (View on PubMed)

Other Identifiers

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I-gel versus air-Q

Identifier Type: -

Identifier Source: org_study_id

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