Trial Outcomes & Findings for Miller Straight Blade vs Macintosh Blade (NCT NCT02664532)
NCT ID: NCT02664532
Last Updated: 2016-03-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
60 seconds
Results posted on
2016-03-11
Participant Flow
Participant milestones
| Measure |
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 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.
Macintosh group: Macintosh blade was used for laryngoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Miller Straight Blade vs Macintosh Blade
Baseline characteristics by cohort
| Measure |
Miller Group
n=75 Participants
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 group: Miller blade was used for laryngoscopy
|
Macintosh Group
n=75 Participants
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 group: Macintosh blade was used for laryngoscopy
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 secondsDegree 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
Outcome measures
| Measure |
Miller Group
n=75 Participants
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 group: Miller blade was used for laryngoscopy
|
Macintosh Group
n=75 Participants
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 group: Macintosh blade was used for laryngoscopy
|
|---|---|---|
|
Ease of Intubation or Degree of Difficulty With Intubation
Grade 1
|
52 participants
|
54 participants
|
|
Ease of Intubation or Degree of Difficulty With Intubation
Grade 2
|
23 participants
|
16 participants
|
|
Ease of Intubation or Degree of Difficulty With Intubation
Grade 3
|
0 participants
|
5 participants
|
|
Ease of Intubation or Degree of Difficulty With Intubation
Grade 4
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 60 secondsGrade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible
Outcome measures
| Measure |
Miller Group
n=75 Participants
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 group: Miller blade was used for laryngoscopy
|
Macintosh Group
n=75 Participants
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 group: Macintosh blade was used for laryngoscopy
|
|---|---|---|
|
Cormack Lehane Grading
Grade 1
|
69 participants
|
51 participants
|
|
Cormack Lehane Grading
Grade 2
|
6 participants
|
18 participants
|
|
Cormack Lehane Grading
Grade 3
|
0 participants
|
6 participants
|
|
Cormack Lehane Grading
Grade 4
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 180 secondsAn 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.
Outcome measures
| Measure |
Miller Group
n=75 Participants
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 group: Miller blade was used for laryngoscopy
|
Macintosh Group
n=75 Participants
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 group: Macintosh blade was used for laryngoscopy
|
|---|---|---|
|
Number of Intubation Attempts
Single Attempt
|
75 participants
|
74 participants
|
|
Number of Intubation Attempts
Second attempt
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 180 secondsThe 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.
Outcome measures
| Measure |
Miller Group
n=75 Participants
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 group: Miller blade was used for laryngoscopy
|
Macintosh Group
n=75 Participants
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 group: Macintosh blade was used for laryngoscopy
|
|---|---|---|
|
Total Laryngoscopy Duration in Seconds
|
23 Seconds
Standard Deviation 7
|
20.5 Seconds
Standard Deviation 7.7
|
Adverse Events
Miller Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Macintosh Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place