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

NCT01535742 | Completed

• 1 other identifier: Air-Q versus Ambu-Aura-i
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tracheal Intubation in Children

Keywords

laryngeal mask airway; children; tracheal intubation; fiberoptic bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Ease and time to successful tracheal intubation

  from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed

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

Secondary Outcomes (7)

• Ease and time to place 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 and tracheal tube

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

• 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

• Time to remove device

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

Study Arms (4)

Ambu Aura-i size 1.5

EXPERIMENTAL

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

Device: Ambu Aura-i size 1.5

air-Q size 1.5

EXPERIMENTAL

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

Device: air-Q ILA size 1.5

Ambu Aura-i size 2

EXPERIMENTAL

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

Device: Ambu Aura-i size 2

air-Q size 2

EXPERIMENTAL

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

Device: air-Q ILA size 2

Interventions

Ambu Aura-i size 1.5 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 1.5

air-Q ILA size 1.5 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

Ambu Aura-i size 2 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

air-Q ILA size 2 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

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
• Weight 5-20 kg
• Age one month-six years

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Related Publications (4)

• 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.

  PMID: 21917058 BACKGROUND

• 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.

  PMID: 21081777 BACKGROUND

• 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.

  PMID: 21973052 BACKGROUND

• 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.

  PMID: 20716075 BACKGROUND

Study Officials

• Narasimhan Jagannathan, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  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: February 13, 2012
• First Posted: February 20, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 29, 2012

Record last verified: 2012-06

Locations

US (1)