Comparison of Miller's Blade and Airtraq Laryngoscope in Children

• ClinicalTrials.gov Identifier: NCT02423317
• Recruitment Status: Completed
• First Posted: April 22, 2015
• Results First Posted: March 9, 2016
• Last Update Posted: March 9, 2016
• Sponsor: Government Medical College, Haldwani
• Information provided by (Responsible Party): Bikramjit Das, Government Medical College, Haldwani

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intubation, Intratracheal	Device: Intubation with Miller's blade; Device: Intubation with Airtraq	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
• Study Start Date: May 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.
Experimental: Intubation with Airtraq laryngoscope; 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.	Device: Intubation with Airtraq; Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Number of Intubation in First Attempts; [ Time Frame: 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.
2. Ease of Intubation. [ Time Frame: 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.
3. Percentage of Glottic Opening Scoring. [ Time Frame: 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
4. Overall Intubation Success Rate. [ Time Frame: 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.
5. Number of Esophageal Intubation. [ Time Frame: 5 minutes ]
   Insertion of tracheal tube inside the esophagus
6. Number of Participants With Airway Trauma [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Government Medical College, Haldwani

Investigators

• Study Director: Shahin N Jamil, M.D.; J.N.Medical College, Aligarh Muslim University

More Information

Additional Information:

Official web site of Airtraq optical laryngoscope 

Publications:

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.

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.

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.

• Responsible Party: Bikramjit Das, Assistant Professor, Government Medical College, Haldwani
• ClinicalTrials.gov Identifier: NCT02423317
• Other Study ID Numbers: DN 182/FM
• First Posted: April 22, 2015
• Results First Posted: March 9, 2016
• Last Update Posted: March 9, 2016
• Last Verified: February 2016