An interventional study of Miller group and Macintosh group in Intubation; Difficult, sponsored by Tata Main Hospital. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by Tata Main Hospital · Not applicable and Interventional
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.
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.
Tata Main Hospital is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Miller blade was used for laryngoscopy
Macintosh blade was used for laryngoscopy
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
Time frame: 60 seconds
Cormack Lehane Grading
Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible
Time frame: 60 seconds
Number of Intubation Attempts
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.
Time frame: 180 seconds
Total Laryngoscopy Duration in 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.
Time frame: 180 seconds
| Milestone | Miller Group | Macintosh Group |
|---|---|---|
| Started | 75 | 75 |
| Completed | 75 | 75 |
| Not completed | 0 | 0 |
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
| participants | Miller Group | Macintosh Group |
|---|---|---|
| Grade 1 | 52 | 54 |
| Grade 2 | 23 | 16 |
| Grade 3 | 0 | 5 |
| Grade 4 | 0 | 0 |
Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible
| participants | Miller Group | Macintosh Group |
|---|---|---|
| Grade 1 | 69 | 51 |
| Grade 2 | 6 | 18 |
| Grade 3 | 0 | 6 |
| Grade 4 | 0 | 0 |
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.
| participants | Miller Group | Macintosh Group |
|---|---|---|
| Single Attempt | 75 | 74 |
| Second attempt | 0 | 1 |
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.
| Seconds | Miller Group | Macintosh Group |
|---|---|---|
| Total Laryngoscopy Duration in Seconds | 23 ± 7 | 20.5 ± 7.7 |
Collected over During the duration of admission in the hospital. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Miller Group | — | 0/75 (0%) | 0/75 (0%) |
| Macintosh Group | — | 0/75 (0%) | 0/75 (0%) |
ASA grade I \& II patients aged between 18 to 70 years of both genders undergoing elective surgery requiring general anesthesia with oral endotracheal intubation were included in the study.
| Age, Categorical(Participants) | Miller Group | Macintosh Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 75 | 75 | 150 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Miller Group | Macintosh Group | Total |
|---|---|---|---|
| Mean | 44.8 ± 13.1 | 48.2 ± 14 | 47.6 ± 13.7 |
| Sex: Female, Male(Participants) | Miller Group | Macintosh Group | Total |
|---|---|---|---|
| Female | 46 | 47 | 93 |
| Male | 29 | 28 | 57 |
| Region of Enrollment(participants) | Miller Group | Macintosh Group | Total |
|---|---|---|---|
| India | 75 | 75 | 150 |
No study locations are listed for this record.
Plan to share: No
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Tata Main Hospital