Impact of Covid-19 Aerosol Box On Intubation Success Rate

• ClinicalTrials.gov Identifier: NCT06042829
• Recruitment Status: Completed
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Information provided by (Responsible Party): Universiti Kebangsaan Malaysia Medical Centre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intubation; Difficult or Failed	Device: Intubation using aerosol box; Device: Intubation without aerosol box	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact of Covid-19 Aerosol Box On Intubation Success Rate and Intubation Time
• Actual Study Start Date: November 23, 2020
• Actual Primary Completion Date: October 22, 2021
• Actual Study Completion Date: November 22, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Tracheal intubation time [ Time Frame: 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 :

1. Ease of tracheal intubation [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Malaysia

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia, 56000

Sponsors and Collaborators

Universiti Kebangsaan Malaysia Medical Centre

Investigators

• Principal Investigator: Nurul Najwa Mohd Noor Dr; National University of Malaysia

More Information

• Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
• ClinicalTrials.gov Identifier: NCT06042829
• Other Study ID Numbers: HTM-2020-006
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No