Impact of Covid-19 Aerosol Box On Intubation Success Rate

National University of Malaysia (UKM)

Status: Completed

Conditions: Intubation; Difficult or Failed

Treatments: Device: Intubation using aerosol box; Device: Intubation without aerosol box

Study type: Interventional

Funder types: Other

Identifiers

NCT06042829

HTM-2020-006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intubation with aerosol box

Experimental group

Description:

Aerosol box group where patient will be intubated using aerosol box

Treatment:

Device: Intubation using aerosol box

Intubation without Aerosol box

Active Comparator group

Description:

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

Treatment:

Device: Intubation without aerosol box