Intubation, Intratracheal Clinical Trial
Official title:
A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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