Intubation, Intratracheal
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntubation with Miller's blade
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
DEVICEIntubation with Airtraq
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
Sponsors
Government Medical College, Haldwani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists physical status I-II, 2. elective surgeries requiring tracheal intubation
Exclusion criteria
1. patients with upper respiratory tract symptoms, 2. those at risk of gastroesophageal regurgitation and 3. those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | 5 minutes | It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Intubation. | 5 minutes | 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. |
| Percentage of Glottic Opening Scoring. | 5 minutes | 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 |
| Number of Intubation in First Attempts; | 5 minutes | 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. |
| Number of Esophageal Intubation. | 5 minutes | Insertion of tracheal tube inside the esophagus |
| Number of Participants With Airway Trauma | 5 minutes | Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma. |
| Overall Intubation Success Rate. | 5 minutes | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intubation With Miller's Blade | Intubation With Airtraq Laryngoscope | Total |
|---|---|---|---|
| Age, Continuous | 5.4 years STANDARD_DEVIATION 1.78 | 6.15 years STANDARD_DEVIATION 2.64 | 5.775 years STANDARD_DEVIATION 2.21 |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 19 Participants | 25 Participants | 44 Participants |
| Weight | 15.9 Kg STANDARD_DEVIATION 2.53 | 16.5 Kg STANDARD_DEVIATION 3.87 | 16.2 Kg STANDARD_DEVIATION 3.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intubation With Miller's Blade | Time to Intubation | 15.13 seconds | Standard Deviation 1.33 |
| Intubation With Airtraq Laryngoscope | Time to Intubation | 11.53 seconds | Standard Deviation 0.49 |
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.
Time frame: 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intubation With Miller's Blade | Ease of Intubation. | 5 scores on visual analogue scale |
| Intubation With Airtraq Laryngoscope | Ease of Intubation. | 3 scores on visual analogue scale |
Secondary
Number of Esophageal Intubation.
Insertion of tracheal tube inside the esophagus
Time frame: 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intubation With Miller's Blade | Number of Esophageal Intubation. | 4 esophageal intubation |
| Intubation With Airtraq Laryngoscope | Number of Esophageal Intubation. | 0 esophageal intubation |
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.
Time frame: 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intubation With Miller's Blade | Number of Intubation in First Attempts; | 25 Intubations |
| Intubation With Airtraq Laryngoscope | Number of Intubation in First Attempts; | 29 Intubations |
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.
Time frame: 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intubation With Miller's Blade | Number of Participants With Airway Trauma | 3 participants |
| Intubation With Airtraq Laryngoscope | Number of Participants With Airway Trauma | 1 participants |
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.
Time frame: 5 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intubation With Miller's Blade | Overall Intubation Success Rate. | 30 participants |
| Intubation With Airtraq Laryngoscope | Overall Intubation Success Rate. | 30 participants |
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
Time frame: 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intubation With Miller's Blade | Percentage of Glottic Opening Scoring. | 75 percentage of glottic opening |
| Intubation With Airtraq Laryngoscope | Percentage of Glottic Opening Scoring. | 100 percentage of glottic opening |