Impact of Covid-19 Aerosol Box On Intubation Success Rate

Intubation; Difficult or Failed Clinical Trial

Official title:

Impact of Covid-19 Aerosol Box On Intubation Success Rate and Intubation Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06042829
• Other study ID #: HTM-2020-006
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: November 22, 2021

Study information

• Verified date: September 2023
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 22, 2021
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Device:
• Intubation using aerosol box
Intubation time and ease of intubation using aerosol box
• Intubation without aerosol box
Intubation time and ease of intubation without aerosol box

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	1 year