NCT05108584

Intubation in Coronavirus Disease 19 With Level 3 PPE

Completed NA Last updated 2 May 2025

What this trial tests

NA trial testing PPE Level 3 and Video Laryngoscope in Intubation Complication in 39 participants. Completed in 10 February 2022.

Timeline

19 November 2021

Primary endpoint
4 January 2022

10 February 2022

Quick facts

Lead sponsor	Indonesia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	19 November 2021
Primary completion	4 January 2022
Estimated completion	10 February 2022
Sites	1 location across Indonesia

Drugs / interventions tested

• PPE Level 3 and Video Laryngoscope
• PPE Level 3 and Direct Laryngoscope
• PPE Level 2 and Direct Laryngoscope

Conditions studied

• Intubation Complication — all drugs for Intubation Complication →

Sponsor

Indonesia University

Who can join

Adults 18 to 59, any sex, with Intubation Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The World Health Organization (WHO) declared COVID-19 as a pandemic in April 2020. COVID-19 first discovered in Wuhan, China in December 2019. As of May 4th, 2020, the total number of patients in China was 82,880, the number of deaths was 4,633, the death rate was 3.7%. In Indonesia, until May 4th 2020, there were 11,192 confirmed cases of COVID-19 with a total of 845 deaths. High transmission and death due to the severe acute respiratory syndrome coronavirus 2, patients with respiratory failure symptoms were suspected of having COVID-19 until declared negative. A potential and continuing threatening complication is acute respiratory failure. Patient with Acute Respiratory Distress Syndrome (ARDS) require both respiratory support and oxygen therapy. The choosing of endotracheal intubation is generally indicated in moderate to severe ARDS. Apart from respiratory failure, endotracheal intubation is also commonly performed in patients undergoing surgical procedures under general anesthesia for the management of the patient's airway. To prevent transmission to medical personnel, intubation is carried out using PPE according to the guidelines. Guidance for intubation in COVID-19 patients is recommended to use a video laryngoscope because it offers several advantages such as assisting glottis visualization and making the intubation operator more distant from the patient's mouth when compared to direct laryngoscopes. This study aims to see the effect of using PPE and the type of laryngoscope on the intubation process carried out in the COVID-19 pandemic. This study is a preliminary study aimed at seeing the effect size of the recommended PPE use on the process and success of intubation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Three Tracheal Intubation Procedures Using Personal Protective Equipment, Direct and Video Laryngoscopes: An Open, Randomized, Parallel Clinical Trial.
   Aditianingsih D, Pryambodho P, Antonius Wibowo J, Nissi Leonard E, et al · · 2024 · cited 1× · PMID 40078475 · DOI 10.5812/aapm-148208