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Miller Straight Blade vs Macintosh Blade

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ClinicalTrials.gov Identifier: NCT02664532
Recruitment Status : Completed
First Posted : January 27, 2016
Results First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Dr.Deb Sanjay Nag, Tata Main Hospital

Study Description
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Brief Summary:
The purpose of this prospective open labeled randomized study was to compare the "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in routine intubations in non-difficult airways.

Condition or disease Intervention/treatment Phase
Intubation; Difficult Other: Miller group Other: Macintosh group Not Applicable

Detailed Description:
One hundred and fifty patients with predicted non difficult airway were randomly assigned into two groups. After induction of anaesthesia laryngoscopy was performed with respective blades and trachea intubated. Parameters monitored were: glottis view obtained during laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration of laryngoscopy in seconds and encountered complications.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Miller group
In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
 Other: Miller group
Miller blade was used for laryngoscopy
Macintosh group
In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.
 Other: Macintosh group
Macintosh blade was used for laryngoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Ease of Intubation or Degree of Difficulty With Intubation [ Time Frame: 60 seconds ]
    Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope


Secondary Outcome Measures :
  1. Cormack Lehane Grading [ Time Frame: 60 seconds ]
    Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible

  2. Number of Intubation Attempts [ Time Frame: 180 seconds ]
    An intubation attempt is defined as "intubation activities occurring during a single continuous laryngoscopy maneuver". Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt.

  3. Total Laryngoscopy Duration in Seconds [ Time Frame: 180 seconds ]
    The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All ASA I & II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation

Exclusion Criteria:

  • Patients with anticipated difficult airway
  • Cervical spine disorders
  • Anesthesia requiring rapid sequence induction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664532


Sponsors and Collaborators
Tata Main Hospital
Investigators
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Principal Investigator: Bhanu Pratap Swain, DNB Tata Main Hospital, Jamshedpur,India
More Information
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Responsible Party: Dr.Deb Sanjay Nag, Associate Specialist, Tata Main Hospital
ClinicalTrials.gov Identifier: NCT02664532    
Other Study ID Numbers: PR/JHTMH/09242A
First Posted: January 27, 2016    Key Record Dates
Results First Posted: March 11, 2016
Last Update Posted: March 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No