Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

NCT ID: NCT01535742

Last Updated: 2012-06-29

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.

Detailed Description

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The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.

Conditions

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Tracheal Intubation in Children

Keywords

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laryngeal mask airway children tracheal intubation fiberoptic bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Ambu Aura-i size 1.5

patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight

Group Type EXPERIMENTAL

Ambu Aura-i size 1.5

Intervention Type DEVICE

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

air-Q size 1.5

patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight

Group Type EXPERIMENTAL

air-Q ILA size 1.5

Intervention Type DEVICE

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Ambu Aura-i size 2

patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight

Group Type EXPERIMENTAL

Ambu Aura-i size 2

Intervention Type DEVICE

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

air-Q size 2

patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight

Group Type EXPERIMENTAL

air-Q ILA size 2

Intervention Type DEVICE

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Interventions

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Ambu Aura-i size 1.5

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Intervention Type DEVICE

air-Q ILA size 1.5

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Intervention Type DEVICE

Ambu Aura-i size 2

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Intervention Type DEVICE

air-Q ILA size 2

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children undergoing general anesthesia requiring tracheal intubation
* Weight 5-20 kg
* Age one month-six years

Exclusion Criteria

* ASA class IV, V Emergency procedures
* History of a difficult airway
* Active upper respiratory tract infection
* Children receiving emergent surgery
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

Locations

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Childrens Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. doi: 10.1111/j.1460-9592.2011.03703.x. Epub 2011 Sep 15.

Reference Type BACKGROUND
PMID: 21917058 (View on PubMed)

Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.

Reference Type BACKGROUND
PMID: 21081777 (View on PubMed)

Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x.

Reference Type BACKGROUND
PMID: 21973052 (View on PubMed)

Baker PA, Brunette KE, Byrnes CA, Thompson JM. A prospective randomized trial comparing supraglottic airways for flexible bronchoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):831-8. doi: 10.1111/j.1460-9592.2010.03362.x.

Reference Type BACKGROUND
PMID: 20716075 (View on PubMed)

Other Identifiers

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Air-Q versus Ambu-Aura-i

Identifier Type: -

Identifier Source: org_study_id