Comparison of Miller's Blade and Airtraq Laryngoscope in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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The Airtraq optical laryngoscope has recently been available in pediatric sizes. The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients. This prospective, randomized study was conducted in a tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30) laryngoscope. The primary outcome measures were time of intubation, ease of intubation, number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.

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Detailed Description

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After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.

The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.

Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.

Conditions

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Intubation, Intratracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intubation with Miller's blade

After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.

Group Type ACTIVE_COMPARATOR

Intubation with Miller's blade

Intervention Type DEVICE

Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.

Intubation with Airtraq laryngoscope

After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.

Group Type EXPERIMENTAL

Intubation with Airtraq

Intervention Type DEVICE

Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Interventions

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Intubation with Miller's blade

Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.

Intervention Type DEVICE

Intubation with Airtraq

Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. American Society of Anesthesiologists physical status I-II,
2. elective surgeries requiring tracheal intubation

Exclusion Criteria

1. patients with upper respiratory tract symptoms,
2. those at risk of gastroesophageal regurgitation and
3. those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No