Clinical trial NCT02423317: Comparison of Miller's Blade and Airtraq Laryngoscope in Children
Official title: A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: Government Medical College, Haldwani
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Intubation
timeFrame: 5 minutes
Secondary outcomes:
measure: Number of Intubation in First Attempts;
timeFrame: 5 minutes
measure: Ease of Intubation.
timeFrame: 5 minutes
measure: Percentage of Glottic Opening Scoring.
timeFrame: 5 minutes
measure: Overall Intubation Success Rate.
timeFrame: 5 minutes
measure: Number of Esophageal Intubation.
timeFrame: 5 minutes
measure: Number of Participants With Airway Trauma
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: J.N.Medical College, Aligarh Muslim University
name: Shahin N Jamil, M.D.
role: STUDY_DIRECTOR
References:
citation: Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
citation: Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
citation: White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AY, Medlock KE, Mason DG. A randomised, controlled trial comparing the Airtraq optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia. 2012 Mar;67(3):226-31. doi: 10.1111/j.1365-2044.2011.06978.x.