Impact of Covid-19 Aerosol Box On Intubation Success Rate

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Device: Intubation using aerosol box; Device: Intubation without 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Universiti Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intubation with aerosol box; Aerosol box group where patient will be intubated using aerosol box	Device: Intubation using aerosol box; Intubation time and ease of intubation using aerosol box
Active Comparator: Intubation without Aerosol box; Without aerosol box group whereby patients will be intubated without aerosol box.	Device: Intubation without aerosol box; Intubation time and ease of intubation without aerosol box

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	1 year

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Nurul Najwa Mohd Noor Dr, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): October 22, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HTM-2020-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No