NCT02423317

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 9, 2016

Completed
Last Updated

March 9, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

March 29, 2015

Results QC Date

September 23, 2015

Last Update Submit

February 11, 2016

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Number of Intubation in First Attempts;

    5 minutes

  • Ease of Intubation.

    5 minutes

  • Percentage of Glottic Opening Scoring.

    5 minutes

  • Overall Intubation Success Rate.

    5 minutes

  • Number of Esophageal Intubation.

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

Intubation with Miller's blade

ACTIVE COMPARATOR

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 with Airtraq laryngoscope

EXPERIMENTAL

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

Interventions

Intubation with Miller's bladeDEVICE

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

Intubation with Miller's blade
Intubation with AirtraqDEVICE

Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

Intubation with Airtraq laryngoscope

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologists physical status I-II,
  • elective surgeries requiring tracheal intubation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1111/j.1365-2044.2006.04547.x.

    PMID: 16674623BACKGROUND

  • 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.

    PMID: 22545575BACKGROUND

  • 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.

    PMID: 22321076BACKGROUND

Related Links

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Results Point of Contact

Title
Dr. Bikramjit Das
Organization
Govt. Medical College, Haldwani.
bikramjit.anesth@gmail.com
8937963828

Study Officials

  • Shahin N Jamil, M.D.

    J.N.Medical College, Aligarh Muslim University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 29, 2015

First Posted

April 22, 2015

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 9, 2016

Results First Posted

March 9, 2016

Record last verified: 2016-02