Comparison of Miller's Blade and Airtraq Laryngoscope in Children

Not Applicable

Completed

• Conditions: Intubation, Intratracheal
• Interventions: Device: Intubation with Miller's blade; Device: Intubation with Airtraq

• Registration Number: NCT02423317
• Lead Sponsor: Government Medical College, Haldwani

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2015-03-29
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Results First Submitted: 2015-09-23
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-11
• Last Update Submitted: 2016-02-11
• Results First Posted: 2016-03-09
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation with Miller's blade	Intubation with Miller's blade	After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq laryngoscope	Intubation with Airtraq	After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.

Primary Outcome Measures

Name	Time	Method
Time to Intubation	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 Outcome Measures

Name	Time	Method
Overall Intubation Success Rate.	5 minutes	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.
Number of Intubation in First Attempts;	5 minutes	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.
Ease of Intubation.	5 minutes	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.
Number of Participants With Airway Trauma	5 minutes	Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.
Percentage of Glottic Opening Scoring.	5 minutes	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
Number of Esophageal Intubation.	5 minutes	Insertion of tracheal tube inside the esophagus