Impact of Covid-19 Aerosol Box On Intubation Success Rate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-11-22

Brief Summary

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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.

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Detailed Description

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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

1. To determine whether intubation with aerosol box will require more time for successful intubation as compared to intubation without the box.
2. To compare the ease of intubation and determine whether intubation using aerosol box will require additional airway manipulation as compared to intubation without using the box.

Conditions

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Intubation; Difficult or Failed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intubation with aerosol box

Aerosol box group where patient will be intubated using aerosol box

Group Type EXPERIMENTAL

Intubation using aerosol box

Intervention Type DEVICE

Intubation time and ease of intubation using aerosol box

Intubation without Aerosol box

Without aerosol box group whereby patients will be intubated without aerosol box.

Group Type ACTIVE_COMPARATOR

Intubation without aerosol box

Intervention Type DEVICE

Intubation time and ease of intubation without aerosol box

Interventions

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Intubation using aerosol box

Intubation time and ease of intubation using aerosol box

Intervention Type DEVICE

Intubation without aerosol box

Intubation time and ease of intubation without aerosol box

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years old
2. American Society of Anesthesiologist (ASA) I or II patients
3. Tested negative for COVID-19 prior to surgery
4. Patient scheduled for elective surgery under general anaesthesia

Exclusion Criteria

1. Claustrophobia
2. Difficult airway features
3. Body mass index (BMI) of more than 35 kg/m2
4. Body habitus not physically fit into the aerosol box.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes