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Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.
Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubation with Macintosh laryngoscope | Experimental | 40 patients were intubated with Macintosh laryngoscope after simulating difficult laryngoscopy using rigid neck collar. |
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| Intubation with MacCoy laryngoscope | Active Comparator | 40 patients were intubated with MacCoy laryngoscope after simulating difficult laryngoscopy using rigid neck collar. |
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| Intubation with Airtraq laryngoscope | Active Comparator | 40 patients were intubated with Airtraq laryngoscope after simulating difficult laryngoscopy using rigid neck collar. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation- Macintosh laryngoscope | Device | Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Intubation | Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings. | up to 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geeta Bhandari, M.D. | Professor, Department of Anesthesiology, G.M.C. Haldwani | Principal Investigator |
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30 patients were excluded from the study for not meeting the inclusion criteria.
120 patients were recruited for the study. Recruitment process started in January 2014 and the study ended in December 2014. patients were recruited in the operating rooms of a tertiary care teaching hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intubation With Macintosh Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated. |
| FG001 | Intubation With MacCoy Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated. |
| FG002 | Intubation With Airtraq Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intubation With Macintosh Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Time of Intubation | Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings. | Posted | Mean | Standard Deviation | seconds | up to 10 minutes |
|
up to 30 minutes after extubation
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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 | Intubation With Macintosh Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Airway trauma | Injury, poisoning and procedural complications | Systematic Assessment |
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The intubating anesthetist was not blind to the randomization of the laryngoscope. This could have led to bias. However, the primary outcome i.e. time of intubation was well defined and objective.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geeta Bhandari | Govt. Medical College, Haldwani. | 8958267145 | bhandari_geetantl@rediff.com |
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| Intubation- MacCoy laryngoscope | Device | In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated. |
|
| Intubation- Airtraq laryngoscope | Device | In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed. |
|
| BG001 | Intubation With MacCoy Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated. |
| BG002 | Intubation With Airtraq Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Mallampati grade | The Mallampati classification is based on the structures visualized with maximal mouth opening and tongue protrusion in the sitting position. Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible. | Median | Inter-Quartile Range | units on a scale |
|
| Thyromental distance | Mean | Standard Deviation | cm |
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| OG001 | Intubation With MacCoy Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated. |
| OG002 | Intubation With Airtraq Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed. |
|
|
| 3 |
| 40 |
| 0 |
| 40 |
| EG001 | Intubation With MacCoy Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated. | 5 | 40 | 0 | 40 |
| EG002 | Intubation With Airtraq Laryngoscope | After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation. Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed. | 8 | 40 | 0 | 40 |
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