Airway Management
Conditions
Keywords
intubation, videolaryngoscope, first attempt success rate, ease of intubation, time to intubation
Brief summary
The goal of this clinical trial is to learn if performance of a channelled blade Astra-Vue videolaryngoscope compared to non channelled hyperangulated C-MAC D-blade videolaryngoscope(Karl Storz, Tuttlingen, Germany) in airway management among adults undergoing elective surgery under general anesthesia. The main primary outcomes measured is the overall time taken to intubation, secondary measures includes the first attempt success rate, ease with intubation and associated complication Participants are of adults who planned for elective or semi emergency surgery under general anesthesia. They will be screened and recruited with informed and written consent. Intubation information will be collected
Detailed description
This randomized controlled trial aims to compare the performance of a channelled videolaryngoscope (AstraVue videolaryngoscope) with a non-channelled hyperangulated videolaryngoscope (C-MAC™ D-Blade videolaryngoscope, Karl Storz, Tuttlingen, Germany) in adult patients undergoing elective or semi-emergency surgery under general anaesthesia requiring endotracheal intubation. Participants will be randomly assigned to intubation using either the channelled AstraVue videolaryngoscope or the non-channelled C-MAC D-Blade videolaryngoscope. Standard anaesthesia induction protocols will be followed. The primary outcome is the total time to successful intubation. Secondary outcomes include time to glottic visualization, time from glottic visualization to intubation, first-attempt success rate, number of attempts, need for external laryngeal manipulation, haemodynamic responses, and intubation-related complications. Data will be collected prospectively during the peri-intubation period. The study aims to evaluate whether the channelled design improves intubation efficiency and success compared to the non-channelled videolaryngoscope.
Interventions
DEVICEchannelled blade videolaryngoscope
Intubation with channelled blade videolaryngoscope
DEVICENon channelled hyperangulated blade videolaryngoscope
Intubation done by using Non channelled hyperangulated blade videolaryngoscope
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients aged 18 to 70 years old requiring endotracheal intubation for elective or semi-emergency surgery under general anaesthesia * ASA I, II and stable ASA III patients * Patient with Mallampati Score Grade 1 to 3
Exclusion criteria
* Patients with known airway abnormalities or anticipated difficult intubation, * Patients with desaturation before intubation, * Patients with high risk for aspiration requiring rapid sequence induction * Patient with known cervical pathology. * Patient refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time to intubation | During the intubation procedure (within minutes after induction of general anaesthesia) | time from insertion of laryngoscope blade through incisor teeth to visualization of Endotracheal tube into trachea, measured in seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of intubation | During the intubation procedure an immediate post-intubation period (within minutes after induction of general anaesthesia) | Ease of intubation assessed using a modified Intubation Difficulty Scale (IDS), which includes parameters such as number of attempts, additional operators, alternative techniques, lifting force, external laryngeal pressure, vocal cord position, and intubation difficulty. The total score ranges from 0 to ≥5, where a score of 0 classified as easy, 1 to 5 classified as slight difficulty, and \>5 as moderate to major difficulty, generally higher score means increasing difficulty |
| Change in Mean Arterial Pressure from baseline | Baseline taken during induction prior to intubation, second reading repeated at 1 minute after successful intubation | Change in Mean arterial pressure measured at 1 minute after successful intubation, expressed as percentage change from baseline value |
| Change in Heart rate from baseline | Baseline measured prior to intubation, second reading repeat at 1 minute post intubation | Change in heart rate measured at 1 minute after succesful intubation, expressed as percentage change from baseline value |
| First attempt success rate | During the intubation procedure(within minutes after induction of general anaesthesia) | Successful endotracheal intubation on the first attempt, measured as a proportion of total intubations(%) |
| Time to Glottic Visualization | During the intubation procedure(within minutes after induction of general anaesthesia) | time from insertion of laryngoscope blade to visualization of glottis, measured in seconds |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORWei Yen Yeoh
Universiti Malaya
Outcome results
None listed