Impact of Covid-19 Aerosol Box On Intubation Success Rate

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed
• Interventions: Device: Intubation using aerosol box; Device: Intubation without aerosol box

• Registration Number: NCT06042829
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-23
• Study First Submitted: 2021-06-15
• Primary Completion: 2021-10-22
• Study Completion: 2021-11-22
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation with aerosol box	Intubation using aerosol box	Aerosol box group where patient will be intubated using aerosol box
Intubation without Aerosol box	Intubation without aerosol box	Without aerosol box group whereby patients will be intubated without aerosol box.

Primary Outcome Measures

Name	Time	Method
Tracheal intubation time	1 year	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)

Secondary Outcome Measures

Name	Time	Method
Ease of tracheal intubation	1 year	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.

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia