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NCT Number: NCT05108584

Intubation in Coronavirus Disease 19 With Level 3 PPE

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.

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Key information

Conditions

Intubation Complication COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PPE Level 3 and Video Laryngoscope

Procedure

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

PPE Level 3 and Direct Laryngoscope

Procedure

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

PPE Level 2 and Direct Laryngoscope

Procedure

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

Primary outcomes

  1. Total duration of the intubation process

    Time frame: During the procedure

    The 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

  2. Success of intubation process as assessed by number of trials

    Time frame: During the procedure

    The sum amount of trials needed to successfully place an endotracheal tube to the respiratory system

  3. Safety as assessed by number of participants experiencing complications

    Time frame: During the procedure

    Number of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Intubation Procedure in COVID-19 Pandemic

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
May 2, 2025

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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