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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miller group | Experimental | 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. |
|
| Macintosh group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miller group | Other | Miller blade was used for laryngoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 seconds |
| Number of Intubation Attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhanu Pratap Swain, DNB | Tata Main Hospital, Jamshedpur,India | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 60 seconds |
|
During the duration of admission in the hospital
No adverse event was reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Deb Sanjay Nag | Tata Main Hospital | +91-7763807101 | debsanjay@gmail.com |
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| Macintosh group |
| Other |
Macintosh blade was used for laryngoscopy |
|
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 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | All patients were from India (Jamshedpur) | Number | participants |
|
| OG001 | 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 |
|
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| Secondary | 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 | Posted | Number | participants | 60 seconds |
|
|
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| Secondary | 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. | Posted | Number | participants | 180 seconds |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | 180 seconds |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | 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 | 0 | 75 | 0 | 75 |
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| Grade 3 |
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| Grade 4 |
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