Clinical Trials Directory

Trials / Completed

CompletedNCT02423317

Comparison of Miller's Blade and Airtraq Laryngoscope in Children

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Government Medical College, Haldwani · Academic / Other
Sex
All
Age
2 Years – 10 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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

Interventions

TypeNameDescription
DEVICEIntubation with Miller's bladeIntubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
DEVICEIntubation with AirtraqIntubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Timeline

Start date
2013-05-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2015-04-22
Last updated
2016-03-09
Results posted
2016-03-09

Source: ClinicalTrials.gov record NCT02423317. Inclusion in this directory is not an endorsement.