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The Airtraq optical laryngoscope has recently been available in pediatric sizes. The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients. This prospective, randomized study was conducted in a tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30) laryngoscope. The primary outcome measures were time of intubation, ease of intubation, number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.
After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.
The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.
Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubation with Miller's blade | Active Comparator | After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube. |
|
| Intubation with Airtraq laryngoscope | Experimental | After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation with Miller's blade | Device | Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation | It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intubation in First Attempts; | A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt. | 5 minutes |
| Ease of Intubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahin N Jamil, M.D. | J.N.Medical College, Aligarh Muslim University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16674623 | Background | Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x. | |
| 22545575 | Background | Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7. |
| Label | URL |
|---|---|
| Official web site of Airtraq optical laryngoscope | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intubation With Miller's Blade | After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube. Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade. |
| FG001 | Intubation With Airtraq Laryngoscope | After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube. Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intubation With Miller's Blade | After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube. Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 to Intubation | It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform | Posted | Mean | Standard Deviation | seconds | 5 minutes |
|
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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 Miller's Blade | After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube. Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bikramjit Das | Govt. Medical College, Haldwani. | 8937963828 | bikramjit.anesth@gmail.com |
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| ID | Term |
|---|---|
| D007440 | Intubation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Intubation with Airtraq | Device | Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq. |
|
The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation. |
| 5 minutes |
| Percentage of Glottic Opening Scoring. | The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch | 5 minutes |
| Overall Intubation Success Rate. | It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing. | 5 minutes |
| Number of Esophageal Intubation. | Insertion of tracheal tube inside the esophagus | 5 minutes |
| Number of Participants With Airway Trauma | Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma. | 5 minutes |
| 22321076 | Background | White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AY, Medlock KE, Mason DG. A randomised, controlled trial comparing the Airtraq optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia. 2012 Mar;67(3):226-31. doi: 10.1111/j.1365-2044.2011.06978.x. |
| BG001 |
| Intubation With Airtraq Laryngoscope |
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube. Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
|
|
| Secondary | Number of Intubation in First Attempts; | A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt. | Posted | Number | Intubations | 5 minutes |
|
|
|
| Secondary | Ease of Intubation. | The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation. | Posted | Median | Inter-Quartile Range | scores on visual analogue scale | 5 minutes |
|
|
|
| Secondary | Percentage of Glottic Opening Scoring. | The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch | Posted | Median | Inter-Quartile Range | percentage of glottic opening | 5 minutes |
|
|
|
| Secondary | Overall Intubation Success Rate. | It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing. | Posted | Number | participants | 5 minutes |
|
|
|
| Secondary | Number of Esophageal Intubation. | Insertion of tracheal tube inside the esophagus | Posted | Number | esophageal intubation | 5 minutes |
|
|
|
| Secondary | Number of Participants With Airway Trauma | Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma. | Posted | Number | participants | 5 minutes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Intubation With Airtraq Laryngoscope | After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube. Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq. | 0 | 30 | 0 | 30 |
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