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Intubation in Coronavirus Disease 19 With Level 3 PPE

The Intubation Procedure in COVID-19 Pandemic

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05108584
Enrollment
39
Registered
2021-11-05
Start date
2021-11-19
Completion date
2022-02-10
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Keywords

COVID-19, Intubation process, Personal protective equipment (PPE), Laryngoscope

Brief summary

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.

Interventions

PROCEDUREPPE Level 3 and Video Laryngoscope

The operator used level 3 PPE and video laryngoscope for the intubation process

PROCEDUREPPE Level 3 and Direct Laryngoscope

The operator used level 3 PPE and direct laryngoscope for the intubation process

PROCEDUREPPE Level 2 and Direct Laryngoscope

The operator used level 2 PPE and direct laryngoscope for the intubation process

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* Age 18 to 59 years old * Undergo elective or emergency surgery using general anesthesia with endotracheal tube * BMI below 30 kg/m2

Exclusion criteria

* Airway difficulty as assessed by preoperative assessment * Critical patients with unstable hemodynamics * Suspected or confirmed COVID-19 with ASA 3-5

Design outcomes

Primary

MeasureTime frameDescription
Safety as assessed by number of participants experiencing complicationsDuring the procedureNumber of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)
Total duration of the intubation processDuring the procedureThe sum amount of time needed to complete an intubation process that includes preoxygenation duration, neuromuscular blocker action, laryngoscopy duration, and endotracheal tube position confirmation with ultrasound
Success of intubation process as assessed by number of trialsDuring the procedureThe sum amount of trials needed to successfully place an endotracheal tube to the respiratory system

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026