Impact of Covid-19 Aerosol Box On Intubation Success Rate

NCT06042829 | Completed

• 1 other identifier: HTM-2020-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ease of tracheal intubation

  1 year

Study Arms (2)

Intubation with aerosol box

EXPERIMENTAL

Aerosol box group where patient will be intubated using aerosol box

Device: Intubation using aerosol box

Intubation without Aerosol box

ACTIVE COMPARATOR

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

Device: Intubation without aerosol box

Interventions

Intubation using aerosol box DEVICE

Intubation time and ease of intubation using aerosol box

Intubation with aerosol box

Intubation without aerosol box DEVICE

Intubation time and ease of intubation without aerosol box

Intubation without Aerosol box

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• American Society of Anesthesiologist (ASA) I or II patients
• Tested negative for COVID-19 prior to surgery
• Patient scheduled for elective surgery under general anaesthesia

You may not qualify if:

• Claustrophobia
• Difficult airway features
• Body mass index (BMI) of more than 35 kg/m2
• Body habitus not physically fit into the aerosol box.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Nurul Najwa Mohd Noor Dr

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: September 21, 2023
• Study Start: November 23, 2020
• Primary Completion: October 22, 2021
• Study Completion: November 22, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

MY (1)