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Clinical Trials/NCT06042829
NCT06042829CompletedNot Applicable

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

Universiti Kebangsaan Malaysia Medical Centre2 sites in 1 country60 target enrollmentStarted: November 23, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Tracheal intubation time

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Ease of tracheal intubation(1 year)

Investigators

Sponsor
Universiti Kebangsaan Malaysia Medical Centre
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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