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Clinical Trials/NCT02423317
NCT02423317
Completed
Not Applicable

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

Government Medical College, Haldwani0 sites60 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation, Intratracheal
Sponsor
Government Medical College, Haldwani
Enrollment
60
Primary Endpoint
Time to Intubation
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
May 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Government Medical College, Haldwani
Responsible Party
Principal Investigator
Principal Investigator

Bikramjit Das

Assistant Professor

Government Medical College, Haldwani

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Overall Intubation Success Rate.(5 minutes)
  • Number of Intubation in First Attempts;(5 minutes)
  • Ease of Intubation.(5 minutes)
  • Number of Participants With Airway Trauma(5 minutes)
  • Percentage of Glottic Opening Scoring.(5 minutes)
  • Number of Esophageal Intubation.(5 minutes)

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