Comparison of Miller's Blade and Airtraq Laryngoscope in Children

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423317
• Other study ID #: DN 182/FM
• Status: Completed
• Phase: N/A
• First received: March 29, 2015
• Last updated: February 11, 2016
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2016
• Source: Government Medical College, Haldwani
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Haldwani

References & Publications (3)

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. — View Citation

Sørensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq® versus storz® 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intubation	It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform	5 minutes	No
Secondary	Number of Intubation in First Attempts;	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.	5 minutes	No
Secondary	Ease of Intubation.	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.	5 minutes	No
Secondary	Percentage of Glottic Opening Scoring.	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	5 minutes	No
Secondary	Overall Intubation Success Rate.	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 minutes	No
Secondary	Number of Esophageal Intubation.	Insertion of tracheal tube inside the esophagus	5 minutes	No
Secondary	Number of Participants With Airway Trauma	Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.	5 minutes	No

External Links

•   Official web site of Airtraq optical laryngoscope