Miller Straight Blade vs Macintosh Blade
Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 10, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedResults Posted
Study results publicly available
March 11, 2016
CompletedMarch 11, 2016
February 1, 2016
11 months
January 10, 2016
February 12, 2016
February 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Ease of Intubation or Degree of Difficulty With Intubation
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
60 seconds
Secondary Outcomes (3)
Cormack Lehane Grading
60 seconds
Number of Intubation Attempts
180 seconds
Total Laryngoscopy Duration in Seconds
180 seconds
Study Arms (2)
Miller group
EXPERIMENTALIn 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.
Macintosh group
OTHERIn 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.
Interventions
Eligibility Criteria
You may qualify if:
- All ASA I \& II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation
You may not qualify if:
- Patients with anticipated difficult airway
- Cervical spine disorders
- Anesthesia requiring rapid sequence induction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Limitations and Caveats
Blinding of laryngoscope to the laryngoscopist was not possible. The study was conducted in predicted non-difficult airways and cannot be extrapolated in difficult airway situations.
Results Point of Contact
- Title
- Dr.Deb Sanjay Nag
- Organization
- Tata Main Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Bhanu Pratap Swain, DNB
Tata Main Hospital, Jamshedpur,India
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Specialist
Study Record Dates
First Submitted
January 10, 2016
First Posted
January 27, 2016
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 11, 2016
Results First Posted
March 11, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share