- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664532
Miller Straight Blade vs Macintosh Blade
February 12, 2016 updated by: Dr.Deb Sanjay Nag, Tata Main Hospital
Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Miller blade was used for laryngoscopy
|
|
Other: 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.
|
Macintosh blade was used for laryngoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
60 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
60 seconds
|
|
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.
|
180 seconds
|
|
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.
|
180 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bhanu Pratap Swain, DNB, Tata Main Hospital, Jamshedpur,India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 10, 2016
First Submitted That Met QC Criteria
January 22, 2016
First Posted (Estimate)
January 27, 2016
Study Record Updates
Last Update Posted (Estimate)
March 11, 2016
Last Update Submitted That Met QC Criteria
February 12, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- PR/JHTMH/09242A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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