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The safety of novel medical device must be assessed before being implemented into clinical practice. In the case of aerosol box, one of the safety features concerned includes its impact on intubation and how it affect the probability of efficient intubation in order to avoid risk of hypoxia to patient. As the barrier box is newly invented, there have been limited studies published.
This study aims to compare intubation success rate between intubation with and without aerosol box in real patients, which will determine the chances of efficient intubation and reflect the safety features of the aerosol box.
General Objective To determine whether intubation performed using aerosol box will have a lower chance of success as compared to intubation without using the box.
Specific Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubation with aerosol box | Experimental | Aerosol box group where patient will be intubated using aerosol box |
|
| Intubation without Aerosol box | Active Comparator | Without aerosol box group whereby patients will be intubated without aerosol box. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation using aerosol box | Device | Intubation time and ease of intubation using aerosol box |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tracheal intubation time | Time taken from the laryngoscope blade passes through front incisors, followed by endotracheal intubation being inserted into trachea, and until the first upstroke of the capnograph trace visible as proof of successful tracheal intubation (the measurement is measured in seconds) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of tracheal intubation | Based on scale of tracheal intubation difficulty. The scale is called Intubation Difficulty Scale. Intubation difficulty scale is a numerical score of total intubation difficulty and is based on seven parameters known to be associated with difficult intubation. The seven parameters are number of attempts, number of intubators, number of alternative techniques, Cormack-Lehane laryngoscopy grades, requirement of lifting force of laryngoscopy, application of laryngeal pressure, and mobility of vocal cords. The score will be summed. The degree of difficulty will be categorized into easy (IDS score of 0), slight difficulty (IDS of 1-4) and moderate to major difficulty (IDS of 5 and more) according to the total score. The higher score is associated with a higher prevalence of difficult intubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurul Najwa Mohd Noor Dr | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia | Cheras | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D007440 | Intubation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Intubation without aerosol box | Device | Intubation time and ease of intubation without aerosol box |
|
| 1 year |