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NCT Number: NCT02423317

Comparison of Miller's Blade and Airtraq Laryngoscope in Children

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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Key information

Conditions

Intubation, Intratracheal

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status I-II,
  • elective surgeries requiring tracheal intubation

Exclusion criteria

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

Treatment and study plan

Intubation with Miller's blade

Device

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

Intubation with Airtraq

Device

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

Primary outcomes

  1. Time to Intubation

    Time frame: 5 minutes

    It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform

Secondary outcomes

  1. Number of Intubation in First Attempts;

    Time frame: 5 minutes

    A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.

  2. Ease of Intubation.

    Time frame: 5 minutes

    The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.

  3. Percentage of Glottic Opening Scoring.

    Time frame: 5 minutes

    The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch

  4. Overall Intubation Success Rate.

    Time frame: 5 minutes

    It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.

  5. Number of Esophageal Intubation.

    Time frame: 5 minutes

    Insertion of tracheal tube inside the esophagus

  6. Number of Participants With Airway Trauma

    Time frame: 5 minutes

    Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.

Sponsors and collaborators

Lead sponsor

Government Medical College, Haldwani

Other

Registry information

Official study title

A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2015
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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