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OpenTrials
Completed

NCT Number: NCT06042829

Impact of Covid-19 Aerosol Box On Intubation Success Rate

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.

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Key information

Conditions

Intubation; Difficult or Failed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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

  • To determine whether intubation with aerosol box will require more time for successful intubation as compared to intubation without the box.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intubation using aerosol box

Device

Intubation time and ease of intubation using aerosol box

Intubation without aerosol box

Device

Intubation time and ease of intubation without aerosol box

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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